FDA Adverse Event
Injury
Summary report: N
INSYNC III
MDR report key: 1071922
·
Received July 10, 2008
Report
- Report Number
- 6000094-2008-00333
- Event Type
- Injury
- Date Received
- July 10, 2008
- Date of Event
- December 14, 2007
- Manufacturer
- MEDTRONIC S.A.
- Product Code
- DXY
- PMA / PMN Number
- ASKU
- Removal / Correction Number
- ASKU
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
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: PRELIMINARY TESTING REVEALED NO OUTPUT. FURTHER ANALYSIS DETERMINED THIS WAS THE RESULT OF LIFTED HYBRID BOND WIRES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INSYNC III | IMPLANTABLE PULSE GENERATOR | DXY | MEDTRONIC S.A. | 8042 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Required Intervention | 4568 IMPLANTABLE PACING LEAD| 5071 IMPLANTABLE PACING LEAD| 4024 IMPLANTABLE PACING LEAD |