FDA Adverse Event
Injury
Summary report: N
TENDRIL ST
MDR report key: 1955426
·
Received January 10, 2011
Report
- Report Number
- 2017865-2011-00849
- Event Type
- Injury
- Date Received
- January 10, 2011
- Date of Event
- October 4, 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 Location
- MA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Additional Manufacturer Narrative · 1
FINAL ANALYSIS OF THE LEAD FOUND THAT THE PROXIMAL INSULATION WAS ABRADED AT 22.1 CM TO 22.5 CM FROM THE CONNECTOR PIN. THE DAMAGE INDICATES THAT THE LEAD WAS ABRADED AGAINST ANOTHER DEVICE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE ATRIAL LEAD EXHIBITED NOISE. THE PATIENT WAS PACEMAKER DEPENDENT, AND REPORTED BEING SYMPTOMATIC IN THE PAST MONTH. THE LEAD WAS EXPLANTED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TENDRIL ST | PERMANENT PACEMAKER ELECTRODE | DTB | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1788TC/52 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Required Intervention | 1688TC/58, (B)(4) |