MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-20 for EXTENSION, 30CM 3383 manufactured by St. Jude Medical - Neuromodulation.
[184303300]
Date of event is estimated. During processing of this complaint, attempts were made to obtain complete event, and device information. 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
[184303301]
Device 1 of 2. Related manufacturer reference number: 1627487-2020-03047. It was reported the patient? S ipg became inoperable (exact date unknown). To address the issue, the physician explanted and replaced the patient? S ipg with a new model. During the replacement, diagnostics revealed high impedances with the extension. The physician tested impedances without the extension and found they were normal, and therefore replaced the extension with a new model, which addressed the issue. Postoperatively, effective therapy was restored.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1627487-2020-03046 |
| MDR Report Key | 9860789 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-20 |
| Date of Report | 2020-03-20 |
| Date of Event | 2020-02-26 |
| Date Mfgr Received | 2020-02-26 |
| Device Manufacturer Date | 2016-06-27 |
| Date Added to Maude | 2020-03-20 |
| 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 | 2020-03-20 |
| Returned To Mfg | 2020-03-12 |
| Model Number | 3383 |
| Catalog Number | 3383 |
| Lot Number | 5547731 |
| Device Expiration Date | 2018-05-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| 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 | 2020-03-20 |