BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KAPPA 600 DR

    MDR report key: 1874575 · Received October 19, 2010

    Report

    Report Number
    2647346-2010-00648
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    August 27, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P980035/S9
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PATIENT

    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) DEVICE ANALYSIS FOUND NORMAL BATTERY DEPLETION.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT THE DEVICE "DID NOT LAST AS LONG AS IT WAS SUPPOSED TO". THE PHYSICIAN REPORTED THE DEVICE WAS "QUICK TO [ELECTIVE REPLACEMENT INDICATOR]". LONGEVITY ESTIMATES PERFORMED TWO MONTHS EARLIER HAD INDICATED THE REMAINING LONGEVITY TO BE 11 MONTHS. 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 KAPPA 600 DR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC MED REL, INC. KDR651 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention 4092 IMPLANTABLE PACING LEAD| 4592 IMPLANTABLE PACING LEAD