BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX

    MDR report key: 3992906 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09616
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    July 12, 2000
    Report Date
    May 8, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    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. (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED BY A PATIENT FAMILY MEMBER THAT DURING THE IMPLANT PROCEDURE, THE PHYSICIAN "MISPLACED THE LEADS AND PUNCTURED THE LUNG AND (THE PATIENT) ALMOST DIED." IT WAS ALSO REPORTED THAT THE DEVICE BATTERY "RAN OUT EARLY BECAUSE IT WAS TURNED UP AS HIGH AS IT WOULD GO." FOLLOW-UP WITH THE PHYSICIAN'S CLINIC WAS ATTEMPTED HOWEVER, NO INFORMATION COULD BE OBTAINED. THE DEVICE AND LEADS WERE EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468039 CAPSUREFIX ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5068

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR Hospitalization| L| R 5068-52 LEAD, (B)(4) IPG