BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENPULSE

    MDR report key: 1861506 · Received October 8, 2010

    Report

    Report Number
    6000144-2010-04814
    Event Type
    Injury
    Date Received
    October 8, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P980035/S030
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. EVALUATION SUMMARY: (B)(4) DEVICE ANALYSIS FOUND NORMAL BATTERY DEPLETION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD RAPID BATTERY DECLINE. THE PATIENT HAD BEEN SEEN FOR A ROUTINE FOLLOW-UP AND AT THAT TIME THE BATTERY WAS 2.72 V. IT WAS ESTIMATED THAT THE BATTERY SHOULD LAST BETWEEN 10 AND 29 MONTHS. THE PATIENT WAS SEEN SIX MONTHS LATER AND AT THAT TIME THE BATTERY WAS 2.38 V. THE PATIENT WAS HOSPITALIZED AND THE DEVICE WAS 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 ENPULSE IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC MED REL, INC. E2SR03 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention