FDA Adverse Event
Malfunction
Summary report: N
SENSIA
MDR report key: 2965030
·
Received February 15, 2013
Report
- Report Number
- 3004209178-2013-02294
- Event Type
- Malfunction
- Date Received
- February 15, 2013
- Date of Event
- December 10, 2012
- Report Date
- December 10, 2012
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- NVZ
- PMA / PMN Number
- P980035
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, 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. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WAS CHECKED AND IT HAD REVERTED TO VVI 70. THE DEVICE COULD NOT BE PROGRAMMED OUT OF THE VVI 70 AND NO OTHER PARAMETERS WERE CHANGED. THERE WAS NO INDICATION OF ELECTIVE REPLACEMENT INDICATOR (ERI). 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 |
|---|---|---|---|---|---|---|---|
| 69019 | SENSIA | PULSE GENERATOR, PERMANENT, IMPLANTABLE | NVZ | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | SEDR01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00077 YR | 5076 X 2 IMPLANTABLE PACING LEADS |