FDA Adverse Event
Injury
Summary report: N
CONSULTA CRT-D
MDR report key: 2812505
·
Received October 31, 2012
Report
- Report Number
- 6000144-2012-06217
- Event Type
- Injury
- Date Received
- October 31, 2012
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- NIK
- PMA / PMN Number
- P010031/S084
- Removal / Correction Number
- Z-0111-2011
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, 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: (B)(4) THE DEVICE WAS RETURNED AND ANALYSIS REVEALED NORMAL BATTERY DEPLETION.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WAS AT END OF SERVICE AND THE PHYSICIAN HAD A COMPLAINT ABOUT THE BATTERY LONGEVITY. IT WAS NOTED THAT DEVICE OUTPUTS WERE HIGH DUE TO CHRONICALLY HIGH THRESHOLDS ON THE LEFT VENTRICULAR LEAD. THE DEVICE WAS EXPLANTED 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 | CONSULTA CRT-D | IMPLANTABLE PACEMAKER/CARDIO/DEFIB | NIK | MEDTRONIC MED REL, INC. | D224TRK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Hospitalization| R | 4196 IMPLANTABLE PACING LEAD| 6947 IMPLANTABLE TACHY LEAD| 5076 IMPLANTABLE PACING LEAD |