FDA Adverse Event
Malfunction
Summary report: N
CONSULTA CRT-P
MDR report key: 2955336
·
Received February 11, 2013
Report
- Report Number
- 9614453-2013-00290
- Event Type
- Malfunction
- Date Received
- February 11, 2013
- Date of Event
- December 4, 2012
- Report Date
- December 4, 2012
- Manufacturer
- IPG MFG SWITZERLAND
- Product Code
- NVZ
- PMA / PMN Number
- P010015
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCT: 4076 IMPLANTABLE PACING LEAD 2012 (B)(6). (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE DID NOT HAVE ANY DIAGNOSTIC OR COUNTER DATA. IT WAS NOTED THAT THE DEVICE WAS PROGRAMMED TO SINGLE CHAMBER MODE, WITH THE ATRIAL PORT PLUGGED. THE DEVICE IS STILL 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 |
|---|---|---|---|---|---|---|---|
| 59632 | CONSULTA CRT-P | PULSE GENERATOR, PERMANENT, IMPLANTABLE | NVZ | IPG MFG SWITZERLAND | C4TR01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 4195 IMPLANTABLE PACING LEAD |