FDA Adverse Event
Injury
Summary report: N
SIGMA 300 DR
MDR report key: 2812947
·
Received October 31, 2012
Report
- Report Number
- 6000094-2012-02359
- Event Type
- Injury
- Date Received
- October 31, 2012
- Manufacturer
- MEDTRONIC S.A.
- Product Code
- DXY
- PMA / PMN Number
- P980035/S2
- Removal / Correction Number
- Z-1516-2009
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- 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: (B)(4) PRELIMINARY TESTING REVEALED NO OUTPUT AND NO TELEMETRY. THE NO OUTPUT AND NO TELEMETRY CONDITIONS WERE THE RESULT OF LIFTED HYBRID BOND WIRES.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE COULD NOT BE INTERROGATED. IT WAS ALSO REPORTED THAT THE PREVIOUS INTERROGATION HAD SHOWED THE REMAINING BATTERY LIFE OF THE DEVICE TO BE APPROXIMATELY ONE YEAR. THE DEVICE WAS EXPLANTED AND 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 300 DR | IMPLANTABLE PULSE GENERATOR | DXY | MEDTRONIC S.A. | SDR303 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R | 5076 IMPLANTABLE PACING LEAD| 4092 IMPLANTABLE PACING LEAD |