FDA Adverse Event
Injury
Summary report: N
TENDRIL ST
MDR report key: 3923339
·
Received July 9, 2014
Report
- Report Number
- 2017865-2014-14629
- Event Type
- Injury
- Date Received
- July 9, 2014
- Date of Event
- April 1, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- NVN
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
FINAL ANALYSIS NOTED INSULATION ABRASION EXPOSING THE OUTER COIL AT 6.5 CM FROM THE CONNECTOR PIN. THE ABRASION IS CONSISTENT WITH THAT OF EXPOSURE TO FRICTION WITH ANOTHER IMPLANTABLE DEVICE. THIS COULD CAUSE THE REPORTED NOISE PROBLEM.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE RIGHT ATRIAL LEAD WAS EXPLANTED AND REPLACED DURING ROUTINE DEVICE CHANGE OUT. UPON DEVICE INTERROGATION, MULTIPLE EPISODES OF AUTO MODE SWITCH DUE TO NOISE WERE NOTED. UPON EXPLANT INSULATION ABRASION WAS NOTED ON THE LEAD. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 401227 | TENDRIL ST | PERMANENT PACEMAKER ELECTRODE | NVN | ST. JUDE MEDICAL, INC., CRMD | 1888TC/52 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR |