MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-02-12 for GUARDIAN? CRANIAL BURR HOLE COVER SYSTEM 6010 manufactured by St. Jude Medical - Neuromodulation.
[179116451]
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
[179116452]
Related manufacturer reference number: 1627487-2020-01568, 1627487-2020-01569, 1627487-2020-01570, 1627487-2020-01572. It was reported that the patient had an erosion which lead to an infection at the lead and extension site junction behind the ear. As a result, surgical intervention took place on (b)(6) 2020 wherein the patient had their entire system explanted. No abbott rep was present at the time of surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1627487-2020-01573 |
| MDR Report Key | 9701291 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-12 |
| Date of Report | 2020-02-12 |
| Date of Event | 2020-01-30 |
| Date Mfgr Received | 2020-01-30 |
| Device Manufacturer Date | 2019-02-05 |
| Date Added to Maude | 2020-02-12 |
| 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 ACCESSORY |
| Product Code | GXR |
| Date Received | 2020-02-12 |
| Model Number | 6010 |
| Catalog Number | 6010 |
| Lot Number | 6835590 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2020-02-12 |