MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-02-21 for EXTENSION, DUAL 4 CHANNEL 20CM 3342 manufactured by St. Jude Medical - Neuromodulation.
[180477603]
Date of event is estimated. Date of explant is unknown. 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
[180477604]
Related manufacturer reference numbers: 1627487-2020-01907, 1627487-2020-01908, 1627487-2020-01909, 1627487-2020-01910. It was reported that the patient experienced ineffective stimulation due to the buildup of excessive scar tissue. In turn, the patient underwent surgical intervention on an unknown date wherein the entire scs system was explanted and replaced with another manufacturer's system. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
[181476948]
During processing of this complaint, attempts were made to obtain complete patient information. 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 | 1627487-2020-01911 |
| MDR Report Key | 9741780 |
| Report Source | CONSUMER |
| Date Received | 2020-02-21 |
| Date of Report | 2020-02-27 |
| Date of Event | 2020-01-29 |
| Date Mfgr Received | 2020-02-23 |
| Device Manufacturer Date | 2009-07-28 |
| Date Added to Maude | 2020-02-21 |
| 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, DUAL 4 CHANNEL 20CM |
| Generic Name | SCS EXTENSION |
| Product Code | GZB |
| Date Received | 2020-02-21 |
| Model Number | 3342 |
| Lot Number | 2822548 |
| Device Expiration Date | 2011-07-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2020-02-21 |