FDA Adverse Event
Malfunction
Summary report: N
ISOFLEX S
MDR report key: 2240433
·
Received September 9, 2011
Report
- Report Number
- 2017865-2011-05504
- Event Type
- Malfunction
- Date Received
- September 9, 2011
- Date of Event
- July 15, 2011
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NVN
- PMA / PMN Number
- P960013
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- 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 ATRIAL LEAD EXHIBITED LOSS OF SENSING. A CHEST X-RAY REVEALED THAT THE LEAD DISLODGED. THE PHYSICIAN ELECTED NOT TO PROCEED WITH ANY SURGERY DUE TO THE HIGH RISK TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ISOFLEX S | PERMANENT PACEMAKER ELECTRODE | NVN | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1642T/52 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR |