FDA Adverse Event
Injury
Summary report: N
TENDRIL STS
MDR report key: 3924036
·
Received July 9, 2014
Report
- Report Number
- 2017865-2014-15001
- Event Type
- Injury
- Date Received
- July 9, 2014
- Date of Event
- May 2, 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
- AU
- 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 THE PATIENT WAS PRESENTED TO THE EMERGENCY DEPARTMENT DUE TO DIAPHRAGMATIC STIMULATION. THE RIGHT ATRIAL LEAD EXHIBITED LOSS OF CAPTURE AND INTERMITTENT SENSING. THE DEVICE WAS REPROGRAMMED TO VVI MODE AND REMAINED IMPLANTED.
Description of Event or Problem · 1
NEW INFORMATION NOTED THAT THE LEAD HAD DISLODGED AND WAS EXPLANTED AND REPLACED ON (B)(6) 2014.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 399413 | TENDRIL STS | PERMANENT PACEMAKER ELECTRODE | NVN | ST. JUDE MEDICAL, INC., CRMD | 2088TC/52 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 31 YR | Required Intervention |