FDA Adverse Event
Injury
Summary report: N
ISOFLEX S
MDR report key: 1073248
·
Received July 11, 2008
Report
- Report Number
- 2017865-2008-01962
- Event Type
- Injury
- Date Received
- July 11, 2008
- Date of Event
- February 24, 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 THAT THE LEAD HAD BEEN DAMAGED 27.5 CM, FROM THE CONNECTOR PIN DUE TO RIB CLAVICLE CRUSH.
Description of Event or Problem · 1
IT WAS REPORTED THAT AN X-RAY REVEALED RIB CLAVICLE CRUSH AND INSULATION DAMAGE ON THE ATRIAL LEAD.
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/52 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |