FDA Adverse Event
Injury
Summary report: N
TENDRIL ST
MDR report key: 2983996
·
Received February 28, 2013
Report
- Report Number
- 2017865-2013-01487
- Event Type
- Injury
- Date Received
- February 28, 2013
- Date of Event
- January 9, 2013
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NVN
- PMA / PMN Number
- P960013
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
PARTIAL LEAD OF THE ELECTRODE PORTION WAS RETURNED IN ONE PIECE. ABRASION DUE TO FRICTION TO ANOTHER DEVICE WAS NOTED AT 5.5 TO 5.7 CM FROM THE DISTAL TIP, WHICH COULD HAVE CONTRIBUTED TO NOISE AND SENSING PROBLEM.
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LEAD EXHIBITED POOR SENSING AND NOISE. THE LEAD WAS EXPLANTED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 87570 | TENDRIL ST | PERMANENT PACEMAKER ELECTRODE | NVN | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1788TC/58 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |