FDA Adverse Event
Injury
Summary report: N
SIGMA 100 VVI
MDR report key: 2123139
·
Received June 14, 2011
Report
- Report Number
- 6000024-2011-00020
- Event Type
- Injury
- Date Received
- June 14, 2011
- Manufacturer
- MEDTRONIC OF CANADA LTD.
- Product Code
- DXY
- PMA / PMN Number
- P980035/S2
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. EVALUATION SUMMARY FOR (B)(4): ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION.
Description of Event or Problem · 1
IT WAS REPORTED THE DEVICE WAS REMOVED AND REPLACED DUE TO PREMATURE BATTERY DEPLETION. THE DEVICE WAS EXPLANTED AND IT IS UNKNOWN IF IT WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SIGMA 100 VVI | IMPLANTABLE PULSE GENERATOR | DXY | MEDTRONIC OF CANADA LTD. | SVVI103 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |