MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2006-01-10 for CARDIOCARE TELETRACE 9431 VJ0006148P manufactured by Medtronic, Inc..
[3283114]
(b)(6) was performing a pacemaker check on pt. On the third trial. (b)(6) began feeling tingling to her hand and then shooting pain. She became confused, disoriented and was in super ventricular fibrillation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2940816 |
| MDR Report Key | 2940816 |
| Report Source | 99 |
| Date Received | 2006-01-10 |
| Date of Report | 2005-08-16 |
| Date of Event | 2005-08-10 |
| Date Facility Aware | 2005-08-10 |
| Report Date | 2005-08-16 |
| Date Reported to FDA | 2005-08-16 |
| Date Reported to Mfgr | 2005-08-16 |
| Date Added to Maude | 2013-02-05 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CARDIOCARE TELETRACE 9431 |
| Generic Name | TELEPHONE ECG TRANSMITTER |
| Product Code | LOS |
| Date Received | 2006-01-10 |
| Model Number | VJ0006148P |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC, INC. |
| Manufacturer Address | MINNEAPOLIS MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2006-01-10 |