FDA Adverse Event
Injury
Summary report: N
KAPPA
MDR report key: 2952934
·
Received February 9, 2013
Report
- Report Number
- 3004209178-2013-01848
- Event Type
- Injury
- Date Received
- February 9, 2013
- Report Date
- November 7, 2012
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- DXY
- PMA / PMN Number
- P980035
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, 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, ANALYZED AND ANALYSIS REVEALED NORMAL BATTERY DEPLETION. CONCOMITANT MEDICAL PRODUCTS: 5592 IMPLANTABLE PACING LEAD: (B)(6) 2003. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE HAD REACHED ELECTIVE REPLACEMENT INDICATOR (ERI). IT WAS NOTED THAT THERE WAS AN ELECTRICAL RESET MESSAGE AND HIGH VENTRICULAR IMPEDANCE. 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 |
|---|---|---|---|---|---|---|---|
| 57323 | KAPPA | PULSE-GENERATOR, PACEMAKER, IMPLANTABLE | DXY | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | KDR901 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R | 5092 IMPLANTABLE PACING LEAD |