FDA Adverse Event
Malfunction
Summary report: N
VERSA DR
MDR report key: 3863122
·
Received June 10, 2014
Report
- Report Number
- 3004209178-2014-10979
- Event Type
- Malfunction
- Date Received
- June 10, 2014
- Date of Event
- March 11, 2014
- Report Date
- March 11, 2014
- 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. CONCOMITANT PRODUCT: 5076-52 LEAD, IMPLANTED: (B)(6) 2004. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) DEVICE SHOWED FREQUENT RESTARTING OF MODE SWITCH EPISODES RESULTING IN POSSIBLE OVER-ESTIMATE OF MODE SWITCH DURATION. 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 |
|---|---|---|---|---|---|---|---|
| 340611 | VERSA DR | PULSE GENERATOR, PERMANENT, IMPLANTABLE | NVZ | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | VEDR01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00089 YR | 5076-58 LEAD |