FDA Adverse Event
Injury
Summary report: N
ISOFLEX S
MDR report key: 1955910
·
Received January 10, 2011
Report
- Report Number
- 2017865-2011-00765
- Event Type
- Injury
- Date Received
- January 10, 2011
- Date of Event
- August 27, 2010
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DTB
- 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 THE PROXIMAL INSULATION AND SUTURE SLEEVE DAMAGED DUE TO EXCESSIVE FORCE WHEN TRYING TO TIE DOWN THE SUTURE SLEEVE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LEAD EXHIBITED CAPTURE THRESHOLD OF GREATER THAN 7 V. THE LEAD WAS EXPLANTED AND REPLACED, AT WHICH TIME, IT WAS OBSERVED THAT THE LEAD WAS -BROKEN-.
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 | 75 YR | Required Intervention |