FDA Adverse Event
Injury
Summary report: N
ENRHYTHM DR
MDR report key: 1990204
·
Received February 15, 2011
Report
- Report Number
- 6000144-2011-00657
- Event Type
- Injury
- Date Received
- February 15, 2011
- Date of Event
- December 1, 2010
- 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
- MN, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
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. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL. EVALUATION SUMMARY: (B)(4) ANALYSIS OF THE DEVICE REVEALED HIGH BATTERY IMPEDANCE.
Additional Manufacturer Narrative · 1
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE HAD PREMATURE BATTERY DEPLETION WITH EARLY ELECTIVE REPLACEMENT INDICATED. IT WAS REMOVED 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 | ENRHYTHM DR | IMPLANTABLE PULSE GENERATOR | DXY | MEDTRONIC MED REL, INC. | P1501DR | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Hospitalization| O| R | 6940 IMPLANTABLE PACING LEAD| 4092 IMPLANTABLE PACING LEAD| 4092 IMPLANTABLE PACING LEAD| 6940 IMPLANTABLE PACING LEAD |