FDA Adverse Event
Injury
Summary report: N
TENDRIL ST
MDR report key: 3802568
·
Received May 9, 2014
Report
- Report Number
- 2017865-2014-13776
- Event Type
- Injury
- Date Received
- May 9, 2014
- Date of Event
- March 31, 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 Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. EVALUATION DESCRIPTION: ANALYSIS FOUND NORMAL DEVICE CHARACTERISTICS. NO INTERVENTION WAS REQUIRED
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING IMPLANT THE LEAD EXHIBITED AN ANOMALY, THE PROCEDURE WAS STOPPED DUE TO TRACHEAL HEMORRHAGE CAUSED BY THE PROCEDURE. THE PATIENTS CONDITION WAS GOOD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 281358 | TENDRIL ST | PERMANENT PACEMAKER ELECTRODE | NVN | ST. JUDE MEDICAL, INC., CRMD | 1888TC/58 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |