MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-27 for 8CH INFINITY DBS FLEX EXTN KIT, 50CM, B 6371 manufactured by St. Jude Medical - Neuromodulation.
[185325214]
Date of event is 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
[185325215]
Device 1 of 2. Related manufacturer reference number: 1627487-2020-03370. It was reported the patient experienced ineffective stimulation on the left extension with no stated falls or trauma. Diagnostics revealed high impedances. To address the issue, the physician explanted the left extension and replaced it with a new model, which resolved the issue. Note: it is unknown which extension is the left extension, therefore both are being reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1627487-2020-03369 |
| MDR Report Key | 9891640 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-27 |
| Date of Event | 2020-03-09 |
| Date Mfgr Received | 2020-03-09 |
| Device Manufacturer Date | 2019-01-24 |
| Date Added to Maude | 2020-03-27 |
| 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 | 8CH INFINITY DBS FLEX EXTN KIT, 50CM, B |
| Generic Name | DBS EXTENSION |
| Product Code | MHY |
| Date Received | 2020-03-27 |
| Returned To Mfg | 2020-03-19 |
| Model Number | 6371 |
| Catalog Number | 6371 |
| Lot Number | 6827093 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2020-03-27 |