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 KIT IMPLANTABLE SLIM TIP LEAD, 90CM MN10450-90A manufactured by St. Jude Medical - Neuromodulation.
[185145793]
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
[185145794]
Related manufacturer reference# 1627487-2020-03110, 1627487-2020-03106, & 1627487-2020-03109. It was reported that the patient experienced ineffective therapy. Troubleshooting revealed high impedances on some of the contacts. As a result, surgical intervention was undertaken on (b)(6) 2020 wherein the ipg and 1 lead at t9 was explanted. Reportedly, the remaining two leads were cut and a portion of the leads remain implanted (related manufacturer reference# 1627487-2020-03112, 1627487-2020-03113, & 1627487-2020-03114 ). Note: both t9 leads are being reported because it's unknown which lead was explanted.
Patient Sequence No: 1, Text Type: D, B5
[188132475]
The results of the investigation are inconclusive since the device was not returned for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1627487-2020-03107 |
| MDR Report Key | 9883218 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date of Event | 2020-03-10 |
| Date Mfgr Received | 2020-03-10 |
| Device Manufacturer Date | 2018-04-04 |
| 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 | KIT IMPLANTABLE SLIM TIP LEAD, 90CM |
| Generic Name | DRG SLIM TIP LEAD |
| Product Code | PMP |
| Date Received | 2020-03-26 |
| Model Number | MN10450-90A |
| Catalog Number | MN10450-90A |
| Lot Number | 6379262 |
| Device Expiration Date | 2020-04-03 |
| 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 | 2020-03-26 |