MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,health professional report with the FDA on 2015-07-21 for ALGOLINE 81102 manufactured by Medtronic Neurosurgery.
[6435562]
On (b)(6) 2015, the trialing catheter broke when they were removing it. They had done a short trial as the patient responded positively. The catheter had been implanted a few hours. When they went to remove it, they felt resistance. They tried to have the patient move in different positions, but still felt resistance and eventually it pulled out but it was clear it had broken. They confirmed the issue with an x-ray and ct scan and they figured approximately 2. 5 cm of catheter was left in the patient. The initial plan was to remove the catheter fragment when the permanent catheter was implanted as the patient was planning to move forward with implant. The patient had a spinal-type headache, but the reporter wasn? T sure if was related to the catheter breaking or just the fact that he had the procedure to put the catheter in. The patient also had left hip and upper thigh pain within 24 hours. Due to the severe pain, the patient was sent to the hospital to have the piece of catheter removed. The piece was removed on (b)(6) 2015. On (b)(6) 2015, the patient? S headache was better and the patient was recovering from the surgery. It was later reported that the patient recovered without sequela. Morphine was used during the trail.
Patient Sequence No: 1, Text Type: D, B5
[14242559]
(b)(4). Analysis results were not available at the time of this report. A follow-up report will be sent when analysis is completed.
Patient Sequence No: 1, Text Type: N, H10
[22521853]
Patient Sequence No: 1, Text Type: N, H10
[22521854]
Corrected information: the initial information should have read the patient recovered "with sequela". Additional information was requested to determine the sequela. If additional information is received, a follow-up report will be sent.
Patient Sequence No: 1, Text Type: D, B5
[26961361]
Analysis of the catheter revealed no significant anomalies.
Patient Sequence No: 1, Text Type: N, H10
[94248252]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2021898-2015-00261 |
| MDR Report Key | 4929630 |
| Report Source | 05,HEALTH PROFESSIONAL |
| Date Received | 2015-07-21 |
| Date of Report | 2015-07-02 |
| Date of Event | 2015-06-29 |
| Date Mfgr Received | 2015-09-15 |
| Device Manufacturer Date | 2015-04-15 |
| Date Added to Maude | 2015-07-21 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DIANE WOLF |
| Manufacturer Street | 7000 CENTRAL AVENUE NE RCW215 |
| Manufacturer City | MINNEAPOLIS MN 55432 |
| Manufacturer Country | US |
| Manufacturer Postal | 55432 |
| Manufacturer Phone | 7635263987 |
| Manufacturer G1 | MEDTRONIC NEUROMODULATION |
| Manufacturer Street | 7000 CENTRAL AVENUE NE RCW215 |
| Manufacturer City | MINNEAPOLIS MN 55432 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55432 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALGOLINE |
| Generic Name | CATHETER, PERCUTANEOUS, INTRASPINAL, SHORT TERM |
| Product Code | MAJ |
| Date Received | 2015-07-21 |
| Returned To Mfg | 2015-07-17 |
| Model Number | 81102 |
| Catalog Number | 81102 |
| Lot Number | D80632 |
| Device Expiration Date | 2019-11-30 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC NEUROSURGERY |
| Manufacturer Address | 125 CREMONA DRIVE GOLETA CA 93117 US 93117 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-07-21 |