MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-03-29 for TRANSMITTER manufactured by Cdi Medical Services.
[10440]
Pt has pacemaker which is regularly tested via transmitter. On 3/17/94 pt was unable to transmit for testing. Mfr contacted via toll free number and said to mail non-functioning transmitter and they would send rptr new product. Pacemaker is still functioning correctly.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1001313 |
| MDR Report Key | 12385 |
| Date Received | 1994-03-29 |
| Date of Report | 1994-03-18 |
| Date of Event | 1994-03-17 |
| Date Added to Maude | 1994-03-31 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRANSMITTER |
| Product Code | DXH |
| Date Received | 1994-03-29 |
| Returned To Mfg | 1994-03-18 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 12385 |
| Manufacturer | CDI MEDICAL SERVICES |
| Manufacturer Address | WINDSOR CT 06095 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1994-03-29 |