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 2020-03-30 for KIT IMPLANTABLE SLIM TIP LEAD, 50CM MN10450-50A manufactured by St. Jude Medical - Neuromodulation.
[185795805]
Patient weight is unable to be obtained. Attempts were made to obtain complete patient information. Further information was not provided. 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
[185795806]
Reference manufacturer number: 1627487-2020-03416. It was reported the patient experienced weakness in their left foot following a lead placement procedure. The physician believes it may be due to inserting the guide wire with the curved side first instead of the straight side. The patient's condition is improving. Note: since it is not known which device is causing the issue, all possible devices are being reported on.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1627487-2020-03415 |
| MDR Report Key | 9899328 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-03-12 |
| Date Mfgr Received | 2020-03-12 |
| Device Manufacturer Date | 2020-01-20 |
| Date Added to Maude | 2020-03-30 |
| 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, 50CM |
| Generic Name | DRG SLIM TIP LEAD |
| Product Code | PMP |
| Date Received | 2020-03-30 |
| Model Number | MN10450-50A |
| Catalog Number | MN10450-50A |
| Lot Number | 7347374 |
| 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 | 2020-03-30 |