MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2020-03-26 for GUARDIAN? CRANIAL BURR HOLE COVER SYSTEM 6010 manufactured by St. Jude Medical - Neuromodulation.
[185140720]
Date of event and therapy dates are estimated. The results/method and conclusion codes along with investigation results will be provided in the final report.
Patient Sequence No: 1, Text Type: N, H10
[185140721]
Related manufacturer reference numbers: 1627487-2020-03165; 1627487-2020-03167; 1627487-2020-03168. It was reported that the patient developed an infection in an unknown location. As a result, the system was explanted. The infection has since resolved, and the patient was re-implanted at a later date.
Patient Sequence No: 1, Text Type: D, B5
[188440673]
During processing of this complaint, attempts were made to obtain patient weight, but it could not be obtained. A review of the lot history record identified no manufacturing nonconformities issued to the reported device that would have contributed to this event. Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1627487-2020-03166 |
| MDR Report Key | 9884228 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date of Event | 2019-08-09 |
| Date Mfgr Received | 2020-03-05 |
| Device Manufacturer Date | 2018-10-24 |
| Date Added to Maude | 2020-03-26 |
| 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 | ANDREA DEITZ |
| Manufacturer Street | 6901 PRESTON ROAD |
| Manufacturer City | PLANO TX 75024 |
| Manufacturer Country | US |
| Manufacturer Postal | 75024 |
| Manufacturer Phone | 9723098000 |
| Manufacturer G1 | ST. JUDE MEDICAL - NEUROMODULATION |
| Manufacturer Street | 6901 PRESTON RD |
| Manufacturer City | PLANO TX 75024 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 75024 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GUARDIAN? CRANIAL BURR HOLE COVER SYSTEM |
| Generic Name | DBS BURR HOLE COVER |
| Product Code | GXR |
| Date Received | 2020-03-26 |
| Model Number | 6010 |
| Catalog Number | 6010 |
| Lot Number | 6698368 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ST. JUDE MEDICAL - NEUROMODULATION |
| Manufacturer Address | 6901 PRESTON RD PLANO TX 75024 US 75024 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-26 |