FDA Adverse Event
Injury
Summary report: N
SIGMA 300 D
MDR report key: 2203360
·
Received August 11, 2011
Report
- Report Number
- 6000094-2011-01527
- Event Type
- Injury
- Date Received
- August 11, 2011
- Manufacturer
- MEDTRONIC S.A.
- Product Code
- DXY
- PMA / PMN Number
- P980035/S2
- Removal / Correction Number
- Z-1510/1519-2009
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- 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 ANALYSIS REVEALED NO OUTPUT AND NO TELEMETRY. FURTHER TESTING REVEALED THAT 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 THERE WAS NO PACEMAKER ACTIVITY NOTED ON THE ELECTROCARDIOGRAM, AND THERE WAS NO TELEMETRY. THE DEVICE WAS REMOVED AND ANOTHER WAS 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 | SIGMA 300 D | IMPLANTABLE PULSE GENERATOR | DXY | MEDTRONIC S.A. | SD303 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 86 YR | Hospitalization| R | (B)(4) COMPETITOR IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACING LEAD |