FDA Adverse Event
Injury
Summary report: N
TENDRIL STS
MDR report key: 3926047
·
Received July 10, 2014
Report
- Report Number
- 2017865-2014-15389
- Event Type
- Injury
- Date Received
- July 10, 2014
- Date of Event
- April 4, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- NVN
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. (B)(6).
Description of Event or Problem · 1
IT WAS REPORTED THAT A CHEST X-RAY REVEALED A SMALL PNEUMOTHORAX, WHICH WAS NOT TREATED. ON 4/5/2014, A REPEAT CHEST X-RAY SHOWED NO PNEUMOTHORAX. THE PATIENT WAS ASYMPTOMATIC. THE RIGHT ATRIAL LEAD REMAINED IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 403203 | TENDRIL STS | PERMANENT PACEMAKER ELECTRODE | NVN | ST. JUDE MEDICAL, INC., CRMD | 2088TC/52 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Other | 1488Q, BPP032187, 7120Q, BNR022928 |