FDA Adverse Event
Injury
Summary report: N
ISOFLEX S
MDR report key: 1073373
·
Received July 11, 2008
Report
- Report Number
- 2017865-2008-02162
- Event Type
- Injury
- Date Received
- July 11, 2008
- Date of Event
- February 7, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DTB
- PMA / PMN Number
- PMA00001
- Removal / Correction Number
- NA
- Adverse Event
- 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 THE DISTAL AND PROXIMAL COILS WERE FRACTURED AT 33.5 CM FROM THE CONNECTOR PIN DUE TO SUBCLAVICULAR CRUSH. DISTAL AND PROXIMAL INSULATIONS WERE ALSO DAMAGED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LEAD SUSTAINED RIB CLAVICLE CRUSH DAMAGE AND EXHIBITED HIGH LEAD IMPEDANCE.
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 | 1646T/58 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |