FDA Adverse Event
Injury
Summary report: N
ISOFLEX S
MDR report key: 1223816
·
Received November 10, 2008
Report
- Report Number
- 2017865-2008-03470
- Event Type
- Injury
- Date Received
- November 10, 2008
- Date of Event
- September 11, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DTB
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NA
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A ROUTINE FOLLOW-UP, HIGH PACING THRESHOLDS OF 3 TO 4 V WERE NOTED. A CHEST X-RAY REVEALED THAT THE LEAD WAS KINKED WITH A POSSIBLE IMPENDING FRACTURE IN THE AREA OF THE SUTURE SLEEVE. THE EXPLANTING SURGEON FELT THAT THE SUTURES WERE TIED TOO TIGHTLY. THE LEAD WAS REPLACED.
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 |