FDA Adverse Event
Malfunction
Summary report: N
ISOFLEX S,
MDR report key: 1223822
·
Received November 10, 2008
Report
- Report Number
- 2017865-2008-03466
- Event Type
- Malfunction
- Date Received
- November 10, 2008
- Date of Event
- September 15, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DTB
- PMA / PMN Number
- PMAP960030
- Removal / Correction Number
- NA
- Report Source
- Manufacturer report
- Reporter Location
- LA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM EXPERIENCING DIZZINESS, FATIGUE AND DIAPHRAGMATIC STIMULATION. THE ATRIAL LEAD EXHIBITED LACK OF SENSING. THE IMPEDANCE TREND GRAPH SHOWED AN IMPEDANCE OF GREATER THAN 2000 OHMS IN THE PREVIOUS MONTH. THE PHYSICIAN INDICATED THAT THE LEAD WAS NOT A PRIORITY, AS THE PULSE GENERATOR WOULD BE CHANGED IN THE NEXT NINE MONTHS. UNTIL THEN, THE DEVICE WAS PROGRAMMED TO VVI.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ISOFLEX S, | PERMANENT PACEMAKER ELECTRODE | DTB | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1642T/46 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |