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 2020-03-30 for 8CH INFINITY DBS FLEX EXTN KIT, 60CM, B 6372 manufactured by St. Jude Medical - Neuromodulation.
[185806337]
Microscopic inspection of the returned extension identified 2 fractures sites where multiple wires were broken. Continuity and impedance tests confirmed all the channels were electrically open. This would have contributed to the patient? S loss of therapy. As the high impedance was observed prior to the revision, the fractures are consistent with the lead being subjected to an overstress condition while in vivo. The source of the stress could not be conclusively determined. Date of event is estimated.
Patient Sequence No: 1, Text Type: N, H10
[185806339]
It was reported the patient experienced a return of symptoms. Patient indicated when he increased stimulation strength, the amplitude would automatically reduce. Diagnostics indicated 7 out of 8 contacts showed high impedance readings. Reprogramming was unable to provide resolution. Surgical intervention was undertaken and the extension was explanted and replaced. No complications were noted during the procedure. Postoperative, the patient is reportedly receiving effective therapy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1627487-2020-03459 |
| MDR Report Key | 9901528 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2019-06-06 |
| Date Mfgr Received | 2019-12-16 |
| Device Manufacturer Date | 2018-07-18 |
| 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 | 8CH INFINITY DBS FLEX EXTN KIT, 60CM, B |
| Generic Name | DBS EXTENSION |
| Product Code | MHY |
| Date Received | 2020-03-30 |
| Returned To Mfg | 2020-01-07 |
| Model Number | 6372 |
| Catalog Number | 6372 |
| Lot Number | 6546698 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 |