FDA Adverse Event
Malfunction
Summary report: N
SERENA CRTP
MDR report key: 8621509
·
Received May 17, 2019
Report
- Report Number
- 9614453-2019-01609
- Event Type
- Malfunction
- Date Received
- May 17, 2019
- Date of Event
- April 27, 2019
- Report Date
- May 17, 2019
- Manufacturer
- MEDTRONIC EUROPE SARL
- Product Code
- NKE
- PMA / PMN Number
- P010015
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED THAT INVALID TRENDING DATA WAS OBSERVED ON A REMOTE TRANSMISSION FROM THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P). QUESTIONABLE CAPTURE WAS ALSO OBSERVED ON THE RIGHT ATRIAL (RA) LEAD. THE DEVICE AND LEAD BOTH REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 414734 | SERENA CRTP | PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION | NKE | MEDTRONIC EUROPE SARL | W1TR05 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 5076 LEAD (X2), 3830 LEAD |