FDA Adverse Event
Malfunction
Summary report: N
TENDRIL STS
MDR report key: 6017776
·
Received October 11, 2016
Report
- Report Number
- 2017865-2016-06504
- Event Type
- Malfunction
- Date Received
- October 11, 2016
- Date of Event
- September 7, 2016
- Report Date
- August 29, 2017
- Manufacturer
- ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
- Product Code
- NVN
- PMA / PMN Number
- P960013
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING IMPLANT PROCEDURE, THE RIGHT VENTRICULAR LEAD HELIX WAS DIFFICULT TO EXTEND. UPON INTERROGATION, THE LEAD EXHIBITED HIGH IMPEDANCE. SEVERAL DIFFERENT IMPLANT POSITIONS WERE ATTEMPTED BUT WERE UNSUCCESSFUL. THE LEAD WAS NOT USED AND REPLACED WITHOUT COMPLICATIONS. THE PATIENT WAS IN STABLE CONDITION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 670837 | TENDRIL STS | PERMANENT PACEMAKER ELECTRODE | NVN | ST. JUDE MEDICAL, INC.(CRM-SYLMAR) | 2088TC/58 | A000023788 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |