FDA Adverse Event
Injury
Summary report: N
TENDRIL ST
MDR report key: 1896643
·
Received November 10, 2010
Report
- Report Number
- 2017865-2010-05066
- Event Type
- Injury
- Date Received
- November 10, 2010
- Date of Event
- September 22, 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
- WV
- 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 PATIENT COMPLAINED OF SYNCOPE AND LIGHTHEADEDNESS WHEN LIFTING ARMS ABOVE HEAD OR BENDING AT THE WAIST. INTERROGATION REVEALED THAT NOISE ON THE ATRIAL LEAD INHIBITED PACING. ON (B)(6) 2010 L EAD FRACTURE DUE TO CRUSH OR FRICTION WITH THE VENTRICULAR LEAD WAS IDENTIFIED. THE LEAD WAS REMOVED 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/46 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Required Intervention | (B)(4) |