BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELECTRODE, PACEMAKER, PERMANENT

    MDR report key: 2964979 · Received February 15, 2013

    Report

    Report Number
    2649622-2013-01998
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    December 31, 2012
    Report Date
    December 31, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT SUMMARY: ANALYSIS FOUND NO ANOMALIES.

    Additional Manufacturer Narrative · 1

    (B)(4). THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD SHOWED "INTERMITTENT LOSS OF CAPTURE" FOUR DAYS AFTER IMPLANTATION. THE LOSS OF CAPTURE COULD NOT BE DUPLICATED VIA ISOMETRICS; THEREFORE, THE PHYSICIAN OPTED TO REPLACE THE LEAD. THE LEAD WAS RETURNED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD SHOWED "INTERMITTENT LOSS OF CAPTURE" FOUR DAYS AFTER IMPLANTATION. THE LOSS OF CAPTURE COULD NOT BE DUPLICATED VIA ISOMETRICS; THEREFORE, THE PHYSICIAN OPTED TO REPLACE THE LEAD. THE LEAD WAS RETURNED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68866 ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR Hospitalization| R (B)(4) IMPLANTABLE PULSE GENERATOR 2012-(B)(4)