MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-11 for ALGOLINE 81102 manufactured by Medtronic Neuromodulation.
[26081252]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[26081253]
On (b)(6) 2015, information was received from a health care provider via a representative regarding a patient who was receiving an unknown drug for a pump trial for cancer pain. The drug concentration, dose, and lot number were not known at the time of the report. The patient's medical history included cancer. The patient's concomitant medications were unobtainable. On (b)(6) 2015, during the implant procedure of the trial catheter the physician attempted to insert the catheter. However, the catheter would not advance beyond two vertebral body levels and the percutaneous catheter was reported as too big for the intrathecal space. The awake male patient reported an uncomfortable paresthesia and shocking down the legs. The physician was extremely worried about a cerebral spinal fluid (csf) leak with such a big catheter (14 gauge needle). This temporary intrathecal catheter would have been removed in three days. The physician then requested the ascenda catheter and needle (16 gauge needle) noting it was much smaller. There were no patient paresthesia complaints and this catheter was inserted to the desired level. However, the physician was still very worried about the possibility of a csf leak due to a 14 gauge puncture hole in the dura from the first failed attempt. No surgical intervention occurred nor was planned. At the time of the report the patient's status was reported as alive-no injury. This issue was reported as resolved at the time of the report. The attempted catheter would not be returned as it was discarded by the customer. The physician expressed that the company should have a safe and small gauge percutaneous intrathecal catheter for temporary use, matching the size of our implanted ascenda catheter. He also mentioned the company should have a catheter labeled for externalization using a catheter extension for buried catheter trials. If additional information is received a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007566237-2015-02566 |
| MDR Report Key | 5070633 |
| Date Received | 2015-09-11 |
| Date of Report | 2015-08-18 |
| Date of Event | 2015-08-18 |
| Date Mfgr Received | 2015-08-18 |
| Date Added to Maude | 2015-09-11 |
| 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 | 0 |
| Brand Name | ALGOLINE |
| Generic Name | CATHETER, PERCUTANEOUS, INTRASPINAL, SHORT TERM |
| Product Code | MAJ |
| Date Received | 2015-09-11 |
| Model Number | 81102 |
| Catalog Number | 81102 |
| Lot Number | D55654 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC NEUROMODULATION |
| Manufacturer Address | 800 53RD AVE NE MINNEAPOLIS MN 554211200 US 554211200 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-09-11 |