MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-01-26 for CURRENT VR RF CD-1211-36Q manufactured by St Jude.
[1279479]
During defibrillation testing, ventricular fibrillation was induced by the st jude fibber. Ventricular fibrillation was seen on the st jude programmer. During event, without warning, there was a loss of telemetry and failure of the implantable defibrillator to deliver therapy. Pt had to be externally defibrillated. No adverse event occurred to the pt. Device was found to be in vvi reset mode, and could not be interrogated. New device was implanted in pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5014550 |
| MDR Report Key | 1590936 |
| Date Received | 2010-01-26 |
| Date of Report | 2010-01-26 |
| Date of Event | 2009-11-23 |
| Date Added to Maude | 2010-02-04 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CURRENT VR RF CD-1211-36Q |
| Generic Name | DEFIBRILLATOR |
| Product Code | MTE |
| Date Received | 2010-01-26 |
| Returned To Mfg | 2009-11-23 |
| Model Number | CURRENT VR |
| Lot Number | 565410 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ST JUDE |
| Manufacturer Address | SYLMAR CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2010-01-26 |