MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-07-29 for MEDTRONIC UNIPOLAR CONNECTOR 4557M - 53 CM manufactured by Medtronic, Inc..
[12801]
Dual chamber rate responsive permanent pacemaker was inserted on 5/29/94. In the or, the pacemaker was noted to be functioning well but the atrial output did not seem to capture the atrium. A chest x-ray was obtained and confirmed proper lead placement prior to the completion of the surgery. The atrium could not be aced with voltages up to 8 volts, and no current could be measured. The atrium also appeared to be electrically insert. 18 hours s/p pacemaker implantation, the patient developed bradycardia and arrested. The arrest was believed to be due to the pacemaker's failure to cature. The patient received cpr and was successfully resuscitated. The pacemaker was subsequently interrogated and reprogrammed. The patient was discharged home without any long term complications.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 18099 |
| MDR Report Key | 18099 |
| Date Received | 1994-07-29 |
| Date of Report | 1994-06-20 |
| Date of Event | 1994-05-30 |
| Date Facility Aware | 1994-06-13 |
| Report Date | 1994-06-20 |
| Date Reported to Mfgr | 1994-06-21 |
| Date Added to Maude | 1994-12-01 |
| 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 | MEDTRONIC UNIPOLAR CONNECTOR |
| Generic Name | PACEMAKER LEAD |
| Product Code | DTA |
| Date Received | 1994-07-29 |
| Model Number | 4557M - 53 CM |
| Device Expiration Date | 1996-03-17 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 1 DAY |
| Implant Flag | Y |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 18027 |
| Manufacturer | MEDTRONIC, INC. |
| Manufacturer Address | MINNEAPOLIS MN 55432 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 1994-07-29 |