FDA Adverse Event
Injury
Summary report: N
ISOFLEX S
MDR report key: 2240215
·
Received September 9, 2011
Report
- Report Number
- 2017865-2011-05523
- Event Type
- Injury
- Date Received
- September 9, 2011
- Date of Event
- May 15, 2011
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NVN
- PMA / PMN Number
- P960013
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- 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. FINAL ANALYSIS FOUND THAT THE INSULATION WAS DAMAGED/ ABRADED AND FOUR TINES WERE MISSING. THE DAMAGED AREA COULD NOT BE EVALUATED BUT COULD HAVE CAUSED A THRESHOLD ANOMALY. THERE IS NO INDICATION OF A MALFUNCTION ANOMALY.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LEAD EXHIBITED HIGH THRESHOLDS. THE LEAD WAS EXPLANTED AND REPLACED.
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 | 1646T/58 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Required Intervention |