BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2032492 · Received March 23, 2011

    Report

    Report Number
    3004209178-2011-02228
    Event Type
    Injury
    Date Received
    March 23, 2011
    Date of Event
    February 1, 2011
    Report Date
    November 2, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    NOTE CORRECTED DATE FOR PREVIOUS SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS HOSPITALIZED DUE TO EPISODES OF NO PACING FROM HER PACEMAKER CAUSING A LOW HEART RATE. THE PACEMAKER WAS OVER-SENSING THE ELECTRIC CURRENT FROM THE IMPLANTABLE NEUROSTIMULATOR (INS) AND MISTAKING IT FOR THE PATIENT'S HEART RHYTHM, RESULTING IN PACEMAKER INHIBITION. THE PACEMAKER WAS REPROGRAMMED ON (B)(6) 2011 TO IGNORE THE INS AND THE PT WAS DOING WELL WITH NO FURTHER ISSUES.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT RECEIVED A NEW PACEMAKER AND WAS DOING WELL WITH NO COMPLAINTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS TOLD THEIR PACEMAKER BATTERY DEPLETED FASTER DUE TO THE INTERSTIM DEVICE. NO INTERVENTION WERE NOTED. AS OF THIS REPORT, NO DEVICES HAVE BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MDT PUERTO RICO OPERATIONS CO 3058 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization LEAD MODEL 3889-28 LOT# V343800 IMPLANTED: UNK EX| LEAD MODEL 3889-28 LOT# V343800 IMPLANTED: UNK EX| IMPLANTED:| LEAD: MODEL 3889, LOT# V343800| EXPLANTED:| PROGRAMMER: MODEL 3037, LOT# NJD094965N