FDA Adverse Event
Injury
Summary report: N
TENDRIL ST
MDR report key: 2013906
·
Received March 10, 2011
Report
- Report Number
- 2017865-2011-01575
- 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
- NA
- 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 ATRIAL LEAD EXHIBITED NOISE AND LOW IMPEDANCE VALUES. ONCE THE POCKET WAS OPENED AN INSULATION ABRASION WAS NOTED, WHICH WAS SUSPECTED TO BE THE CAUSE FOR THE NOISE AND IMPEDANCE ISSUES. IT WAS ALSO NOTED THAT THE LEAD HAD FALLEN. 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 | 1888TC/52 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Required Intervention | (B)(4) |