MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-03-30 for STRATA NSC LUMBOPERITONEAL SHUNT KIT 44421 manufactured by Medtronic Neurosurgery.
[188325743]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[188325744]
It was reported that cerebrospinal fluid had accumulated on the lumbar side of the patient with the lp shunt valve implanted. The lumbar catheter and valve were replaced because the lumbar catheter seemed to be cracked. During the replacement, it could not be found where the cerebrospinal fluid was leaking. The patient's status at the time of the report was alive-no injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2021898-2020-00112 |
| MDR Report Key | 9899384 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-03-17 |
| Date Mfgr Received | 2020-03-23 |
| Date Added to Maude | 2020-03-30 |
| 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 | KATCHA TAYLOR |
| Manufacturer Street | 9775 TOLEDO WAY |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 9496801345 |
| Manufacturer G1 | MEDTRONIC NEUROSURGERY |
| Manufacturer Street | 125 CREMONA DRIVE |
| Manufacturer City | GOLETA CA 93117 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 93117 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STRATA NSC LUMBOPERITONEAL SHUNT KIT |
| Generic Name | SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS |
| Product Code | JXG |
| Date Received | 2020-03-30 |
| Model Number | 44421 |
| Catalog Number | 44421 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| 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. Hospitalization; 2. Required No Informationntervention | 2020-03-30 |