MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-11-18 for ANALYZER / MERLIN PROGRAMMER ST JUDE PROGRAMMER manufactured by St. Jude.
[4003374]
During atrial threshold testing, the psa and device communication "froze" but device communication returned after disconnecting the wireless wand temporarily. All postprocedure parameters were stable. Will send query to the company.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5032963 |
| MDR Report Key | 3480871 |
| Date Received | 2013-11-18 |
| Date of Report | 2013-11-15 |
| Date of Event | 2013-11-12 |
| Date Added to Maude | 2013-11-25 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ANALYZER / MERLIN PROGRAMMER |
| Generic Name | PROGRAMMER PACEMAKER |
| Product Code | DTA |
| Date Received | 2013-11-18 |
| Model Number | ST JUDE PROGRAMMER |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ST. JUDE |
| Manufacturer Address | SUNNYVALE CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-11-18 |