FDA Adverse Event
Malfunction
Summary report: N
VERSA DR
MDR report key: 2123562
·
Received June 14, 2011
Report
- Report Number
- 6000144-2011-02364
- Event Type
- Malfunction
- Date Received
- June 14, 2011
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- NVZ
- PMA / PMN Number
- P980035/S043
- Removal / Correction Number
- ASKU
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
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. EVALUATION SUMMARY: (B)(4) THE DEVICE WAS RETURNED AND PER ANALYSIS FINDINGS, NO ANOMALIES WERE FOUND.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WAS UNABLE TO BE INTERROGATED VIA "AUTO IDENTIFY". WHEN INTERROGATED VIA THE SOFTWARE APPLICATION, DEVICE SHOWED ELECTIVE REPLACEMENT INDICATOR TRIPPED. THE ERI WAS CLEARED AND BATTERY VOLTAGE RETURNED TO NORMAL. THE SALES REP HAD TRIED TO INTERROGATE THE DEVICE SEVERAL DAYS EARLIER, BUT SUSPECTED IT WAS DUE TO COLD. THE DEVICE WAS NOT IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VERSA DR | IMPLANTABLE PULSE GENERATOR | NVZ | MEDTRONIC MED REL, INC. | VEDR01 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 86 YR | Other |