MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-01-25 for CARDIAC PACEMAKERS, INC. 1600 manufactured by Cardiac Pacemakers, Inc..
[17246564]
Aicd was changed due to inappropriate shocks being delivered to the pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 24220 |
| MDR Report Key | 24220 |
| Date Received | 1995-01-25 |
| Date of Report | 1993-11-30 |
| Date of Event | 1993-11-29 |
| Date Facility Aware | 1993-11-29 |
| Report Date | 1993-11-30 |
| Date Added to Maude | 1995-08-09 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CARDIAC PACEMAKERS, INC. |
| Generic Name | AUTOMATIC IMPLANTABLE CARDIO-DEEFIBRILLATOR |
| Product Code | DRK |
| Date Received | 1995-01-25 |
| Returned To Mfg | 1993-11-30 |
| Model Number | 1600 |
| Device Availability | R |
| Device Age | 24 MO |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 24580 |
| Manufacturer | CARDIAC PACEMAKERS, INC. |
| Manufacturer Address | 4100 HAMLINE AVE., N. ST. PAUL MN 551125798 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 1995-01-25 |