MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2001-12-27 for PROFILE MD V-186 SERIES TIERED THERAPY DEFIB. V-186HV3 NA manufactured by St. Jude Medical, Inc. Crmd.
[239508]
The icd was explaned when eri was observed. Extended charge times were also observed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2938836-2001-00455 |
| MDR Report Key | 369031 |
| Report Source | 01,05,07 |
| Date Received | 2001-12-27 |
| Date of Report | 2001-11-27 |
| Date of Event | 2001-11-27 |
| Date Facility Aware | 2001-11-27 |
| Report Date | 2001-11-27 |
| Date Mfgr Received | 2001-11-29 |
| Date Added to Maude | 2002-01-03 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | VERONICA MARTINEZ |
| Manufacturer Street | 701 E. EVELYN AVENUE |
| Manufacturer City | SUNNYVALE CA 94086 |
| Manufacturer Country | US |
| Manufacturer Postal | 94086 |
| Manufacturer Phone | 4087384883 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROFILE MD V-186 SERIES TIERED THERAPY DEFIB. |
| Generic Name | IMPLANTABLE CARDIAC DEFIBRILLATOR |
| Product Code | LSW |
| Date Received | 2001-12-27 |
| Model Number | V-186HV3 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NO INFO |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 358146 |
| Manufacturer | ST. JUDE MEDICAL, INC. CRMD |
| Manufacturer Address | 701 EAST EVELYN AVE. SUNNYVALE CA 94086 US |
| Baseline Brand Name | PROFILE MD V-186 SERIES TIERED THERAPY DEFIB. |
| Baseline Generic Name | IMPLANTABLE CARDIAC DEFIBRILLATOR |
| Baseline Model No | V-186HV3 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2001-12-27 |