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 2020-03-31 for OCTRODE LEAD KIT, 90CM LENGTH 3189 manufactured by St. Jude Medical - Neuromodulation.
[186068911]
The event date is unknown. Concomitant medical products and therapy dates: model: 3189, scs lead, therapy date: unknown the results/method and conclusion codes along with the investigation results will be provided in the final report.
Patient Sequence No: 1, Text Type: N, H10
[186068912]
Device 2 of 2. Reference mfr. Report#: 1627487-2020-03499. It was reported one of the patient's leads was found to have migrated. In turn, the lead was repositioned via surgical intervention on (b)(6) 2020 to address the issue. Note: both of the patient's leads are being reported because it's unknown which lead was repositioned
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1627487-2020-03500 |
| MDR Report Key | 9908452 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date Mfgr Received | 2020-03-13 |
| Device Manufacturer Date | 2019-03-05 |
| Date Added to Maude | 2020-03-31 |
| 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 | OCTRODE LEAD KIT, 90CM LENGTH |
| Generic Name | SCS LEAD |
| Product Code | LGW |
| Date Received | 2020-03-31 |
| Model Number | 3189 |
| Catalog Number | 3189 |
| Lot Number | 6880060 |
| 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 | 2020-03-31 |