FDA Adverse Event
Injury
Summary report: N
TENDRIL SDX
MDR report key: 3924182
·
Received July 9, 2014
Report
- Report Number
- 2017865-2014-15105
- Event Type
- Injury
- Date Received
- July 9, 2014
- Date of Event
- May 7, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- NVN
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
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 ONE DAY POST IMPLANT, THE ATRIAL LEAD EXHIBITED LOSS OF CAPTURE AND SENSING ANOMALY. THE PATIENT WAS RESTLESS DURING THE NIGHT AND THE LEAD HAD DISLODGED. THE LEAD WAS SUCCESSFULLY REPOSITIONED. ON (B)(6) 2014 ONE DAY POST REPOSITIONING PROCEDURE, CAPTURE THRESHOLDS AND SENSING VALUES HAD CHANGED. CHEST X-RAY CONFIRMED LEAD DISLODGEMENT. THE LEAD WAS SUCCESSFULLY REPOSITIONED ON (B)(6) 2014.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 399761 | TENDRIL SDX | PERMANENT PACEMAKER ELECTRODE | NVN | ST. JUDE MEDICAL, INC., CRMD | 1688TC/52 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Required Intervention |