FDA Adverse Event
Malfunction
Summary report: N
TENDRIL ST
MDR report key: 4861377
·
Received June 23, 2015
Report
- Report Number
- 3010215456-2015-00525
- Event Type
- Malfunction
- Date Received
- June 23, 2015
- Date of Event
- April 30, 2015
- Report Date
- May 4, 2015
- Manufacturer
- ST. JUDE MEDICAL, INC. (CRM-KISTA)
- Product Code
- NVN
- PMA / PMN Number
- P960013
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING PLANNED ICD REPLACEMENT PROCEDURE, INTERFERENCE ON THE ATRIAL CHANNEL WAS OBSERVED AND A LEAD MALFUNCTION WAS SUSPECTED. NO FURTHER ACTION WAS TAKEN. THERE WHERE NO CONSEQUENCES REPORTED FOR THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 405880 | TENDRIL ST | PERMANENT PACEMAKER ELECTRODE | NVN | ST. JUDE MEDICAL, INC. (CRM-KISTA) | 1888TC/52 | 2905432 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |