FDA Adverse Event
Malfunction
Summary report: N
ADVISA DR
MDR report key: 3152476
·
Received June 7, 2013
Report
- Report Number
- 9614453-2013-01228
- Event Type
- Malfunction
- Date Received
- June 7, 2013
- Date of Event
- March 28, 2013
- Report Date
- April 12, 2013
- Manufacturer
- IPG MFG SWITZERLAND
- Product Code
- NVZ
- PMA / PMN Number
- P980035
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
PRODUCT EVENT SUMMARY - THE DEVICE WAS RETURNED AND ANALYZED AND NO ANOMALIES WERE FOUND.
Additional Manufacturer Narrative · 1
THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING THE IMPLANT ATTEMPT, THE PHYSICIAN FOUND SENSING AND PACING PROBLEMS WITH THE DEVICE. 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 |
|---|---|---|---|---|---|---|---|
| 252760 | ADVISA DR | PULSE GENERATOR, PERMANENT, IMPLANTABLE | NVZ | IPG MFG SWITZERLAND | A3DR01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |