BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KAPPA

    MDR report key: 3153211 · Received June 8, 2013

    Report

    Report Number
    3004209178-2013-08894
    Event Type
    Injury
    Date Received
    June 8, 2013
    Report Date
    March 4, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, 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. PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. THE RETURNED DEVICE INDICATED NORMAL BATTERY DEPLETION. CONCOMITANT PRODUCT: PRODUCT ID 4074, IMPLANTABLE PACING LEAD, IMPLANTED (B)(6) 2006. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED DURING THE CHANGEOUT OF THE IMPLANTABLE PULSE GENERATOR (IPG) THAT THE PHYSICIAN QUESTIONED WHY THE DEVICE DID NOT LAST LONGER. THE DEVICE WAS REPLACED WITHOUT PROBLEM. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254860 KAPPA PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC MED REL MEDTRONIC PUERTO RICO KDR701

    Patients

    Seq Age Sex Outcome Treatment
    1 00091 YR Hospitalization| R 4574 IMPLANTABLE PACING LEAD