FDA Adverse Event
Injury
Summary report: N
TENDRIL SDX LEAD
MDR report key: 5092413
·
Received September 21, 2015
Report
- Report Number
- 2017865-2015-28724
- Event Type
- Injury
- Date Received
- September 21, 2015
- Date of Event
- September 11, 2015
- Report Date
- September 15, 2015
- Manufacturer
- ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
- Product Code
- NVN
- PMA / PMN Number
- P960013
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE RIGHT ATRIAL LEAD EXHIBITED NOISE, HIGH CAPTURE THRESHOLDS AND DECREASED SENSITIVITY. THE LEAD WAS CAPPED AND REPLACED. THE PATIENT WAS STABLE AND DOING WELL POST PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 624000 | TENDRIL SDX LEAD | PERMANENT PACEMAKER ELECTRODE | NVN | ST. JUDE MEDICAL, INC.(CRM-SYLMAR) | 1688TC/46 | 0002191486 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Required Intervention |