FDA Adverse Event
Death
Summary report: N
ENRHYTHM DR
MDR report key: 2032885
·
Received March 29, 2011
Report
- Report Number
- 6000144-2011-01094
- Event Type
- Death
- Date Received
- March 29, 2011
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- DXY
- PMA / PMN Number
- P980035/S38
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE-RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4) THE DEVICE WAS RETURNED, ANALYZED AND ANALYSIS OF THE DEVICE REVEALED HIGH BATTERY IMPEDANCE.
Description of Event or Problem · 1
THE DEVICE WAS RETURNED TO THE MANUFACTURER AFTER THE PATIENT'S DEATH, ANALYZED, AND TESTED OUT OF SPECIFICATION. THE CAUSE OF DEATH HAS BEEN REQUESTED BUT NOT RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENRHYTHM DR | IMPLANTABLE PULSE GENERATOR | DXY | MEDTRONIC MED REL, INC. | P1501DR | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 85 YR | Death | 5076 X2 IMPLANTABLE PACING LEAD |