FDA Adverse Event
Injury
Summary report: N
TENDRIL ST
MDR report key: 2013905
·
Received March 10, 2011
Report
- Report Number
- 2017865-2011-01586
- Event Type
- Injury
- Date Received
- March 10, 2011
- Date of Event
- December 21, 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
- PA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE VENTRICULAR LEAD EXHIBITED NOISE AND LOW IMPEDANCE VALUES. ONCE THE POCKET WAS OPENED AN INSULATION ABRASION WAS OBSERVED, WHICH WAS SUSPECTED TO BE THE CAUSE OF THE NOISE AND IMPEDANCE ISSUES. THE LEAD WAS CAPPED 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 | 1888TC/58 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Required Intervention | 1888TC/52, (B)(4) |