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 2019-05-15 for GUARDIAN CRANIAL BURR HOLE COVER SYS. 6010 manufactured by St. Jude Medical - Neuromodulation.
[145156378]
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
[145156379]
Mfr. Reference report: 1627487-2019-05653. It was reported that the patient's burr hole caps were infused with tissue and bone calcification. The burr hole cap's jaws could not open and the insert fell apart. The burr hole caps were explanted and replaced on (b)(6) 2019.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1627487-2019-05656 |
| MDR Report Key | 8613209 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-05-15 |
| Date of Report | 2019-06-14 |
| Date Mfgr Received | 2019-06-12 |
| Device Manufacturer Date | 2018-05-08 |
| Date Added to Maude | 2019-05-15 |
| 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 SYS. |
| Generic Name | DBS BURR HOLE CAP |
| Product Code | GXR |
| Date Received | 2019-05-15 |
| Returned To Mfg | 2019-05-13 |
| Model Number | 6010 |
| Lot Number | 6435285 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2019-05-15 |