FDA Adverse Event
Injury
Summary report: N
TENDRIL ST
MDR report key: 3923262
·
Received July 9, 2014
Report
- Report Number
- 2017865-2014-14571
- Event Type
- Injury
- Date Received
- July 9, 2014
- Date of Event
- March 30, 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
- 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 POST VENTRICLE LEAD REVISION, THE RIGHT ATRIAL LEAD EXHIBITED LOSS OF SENSING AND OUT OF RANGE IMPEDANCE. IT WAS SUSPECTED THAT THE LEAD WAS NOT CONNECTED CORRECTLY TO THE DEVICE. UPON POCKET REVISION ON (B)(6) 2014, LEAD CONNECTION SEEMED FINE. THE DEVICE WAS PROGRAMMED TO VVI.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 401670 | TENDRIL ST | PERMANENT PACEMAKER ELECTRODE | NVN | ST. JUDE MEDICAL, INC., CRMD | 1888TC/52 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 88 YR | Required Intervention |