FDA Adverse Event
Malfunction
Summary report: N
VERSA DR
MDR report key: 3992837
·
Received August 8, 2014
Report
- Report Number
- 3004209178-2014-14748
- Event Type
- Malfunction
- Date Received
- August 8, 2014
- Date of Event
- May 6, 2014
- Report Date
- May 6, 2014
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- NVZ
- PMA / PMN Number
- P980035
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- NURSE
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. PRODUCTS: 407645 LEAD IMPLANTED: 2009 (B)(6). (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE AT/AF DIAGNOSTICS ON THE IMPLANTABLE PULSE GENERATOR (IPG) IS UNDERREPORTED. THE PERCENT OF TIME IN MODE SWITCH AND THE NUMBER OF ATRIAL HIGH RATE EPISODES ARE ALSO UNDERREPORTED. 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 |
|---|---|---|---|---|---|---|---|
| 469432 | VERSA DR | PULSE GENERATOR, PERMANENT, IMPLANTABLE | NVZ | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | VEDR01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00093 YR | 407652 LEAD |