FDA Adverse Event
Injury
Summary report: N
SENSIA DR
MDR report key: 1071945
·
Received July 10, 2008
Report
- Report Number
- 2647346-2008-00313
- Event Type
- Injury
- Date Received
- July 10, 2008
- Date of Event
- August 6, 2007
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- DXY
- PMA / PMN Number
- ASKU
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, 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: NO ANOMALIES FOUND. NO ANOMALIES FOUND; FULL LEAD RETURNED AND ANALYZED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SENSIA DR | IMPLANTABLE PULSE GENERATOR | DXY | MEDTRONIC MED REL, INC. | SEDR01 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Required Intervention | 5076 IMPLANTABLE PACING LEAD |