MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2020-03-19 for EXTENSION, 30CM 3383 manufactured by St. Jude Medical - Neuromodulation.
[184042151]
?date of event ? is estimated . 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
[184042152]
Related manufacturer reference numbers: 1627487-2020-02739, 1627487-2020-02740, 1627487-2020-02741. It was reported that patient experienced ineffective therapy. As a result, surgical intervention occurred during which the system was explanted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1627487-2020-02742 |
| MDR Report Key | 9851500 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-18 |
| Date of Event | 2020-02-28 |
| Date Mfgr Received | 2020-02-28 |
| Device Manufacturer Date | 2018-04-27 |
| Date Added to Maude | 2020-03-19 |
| 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 | EXTENSION, 30CM |
| Generic Name | SCS EXTENSION |
| Product Code | GZB |
| Date Received | 2020-03-19 |
| Model Number | 3383 |
| Catalog Number | 3383 |
| Lot Number | 6419801 |
| 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 | 2020-03-19 |