FDA Adverse Event
Injury
Summary report: N
TENDRIL STS
MDR report key: 3923940
·
Received July 9, 2014
Report
- Report Number
- 2017865-2014-14926
- Event Type
- Injury
- Date Received
- July 9, 2014
- Date of Event
- April 9, 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
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE RIGHT VENTRICULAR EXHIBITED AN INSULATION ANOMALY. THE LEAD WAS CAPPED AND REPLACED.
Description of Event or Problem · 1
ADDITIONAL INFORMATION REPORTED STATED THAT THE LEAD HAD EXHIBITED NOISE WHICH COULD BE REPRODUCED WITH ISOMETRICS. NO ELECTRICAL ANOMALIES WERE OBSERVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 401419 | TENDRIL STS | PERMANENT PACEMAKER ELECTRODE | NVN | ST. JUDE MEDICAL, INC., CRMD | 2088TC/52 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Required Intervention |