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 2020-03-26 for 8CH INFINITY DBS LEAD KIT, 40CM, 0.5, B 6172 manufactured by St. Jude Medical - Neuromodulation.
[185147507]
The results/method and conclusion codes along with investigation results will be provided on the final report.
Patient Sequence No: 1, Text Type: N, H10
[185147508]
It was reported that patient experienced ineffective stimulation. As a result, the left lead was explanted, and a new lead was implanted. There was no complication during the procedure. Patient was stable.
Patient Sequence No: 1, Text Type: D, B5
[185299169]
New information received states that new lead implant procedure is anticipated in the near future.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1627487-2020-03299 |
| MDR Report Key | 9886643 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-27 |
| Date of Event | 2020-03-10 |
| Date Mfgr Received | 2020-03-26 |
| Device Manufacturer Date | 2018-11-29 |
| 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 | 8CH INFINITY DBS LEAD KIT, 40CM, 0.5, B |
| Generic Name | DBS LEAD |
| Product Code | MHY |
| Date Received | 2020-03-26 |
| Model Number | 6172 |
| Catalog Number | 6172 |
| Lot Number | 6742512 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 |