FDA Adverse Event
Injury
Summary report: N
CONSULTA CRT-P
MDR report key: 2955139
·
Received February 11, 2013
Report
- Report Number
- 9614453-2013-00216
- Event Type
- Injury
- Date Received
- February 11, 2013
- Date of Event
- November 28, 2012
- Report Date
- November 28, 2012
- Manufacturer
- IPG MFG SWITZERLAND
- Product Code
- NVZ
- PMA / PMN Number
- P010015
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- PHYSICIAN
Narratives
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 : 4194 IMPLANTABLE PACING LEAD: (B)(6) 2012. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT ONE DAY POST IMPLANT, THE DEVICE WAS NOT COLLECTING DIAGNOSTIC DATA AND EVEN THOUGH NO ATRIAL LEAD WAS IMPLANTED, ATRIAL SENSED EVENTS WERE BEING SEEN AFTER THE BI-VENTRICULAR PACE. THE DEVICE PROGRAMMING WAS ADJUSTED AND THE DEVICE REMAINS 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 |
|---|---|---|---|---|---|---|---|
| 59626 | CONSULTA CRT-P | PULSE GENERATOR, PERMANENT, IMPLANTABLE | NVZ | IPG MFG SWITZERLAND | C4TR01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00087 YR | Required Intervention | 5076 IMPLANTABLE PACING LEAD |