BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 2102376 · Received May 20, 2011

    Report

    Report Number
    3004209178-2011-03717
    Event Type
    Malfunction
    Date Received
    May 20, 2011
    Date of Event
    February 1, 2011
    Report Date
    April 25, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A LOSS OF THERAPEUTIC EFFECT. PT SAID HE WAS ON PROGRAM 3 AT 3.8 VOLTS AND EVERY SECOND, HE FELT A SMALL JOLT IN THE GROIN OR A THUD FEELING. WHEN HE TOOK THE ANTENNA OFF, IT WENT AWAY, WHILE HE WAS JUST SITTING. PT SAID FOR 2-3 MONTH NOT GETTING MUCH OF ANYTHING. HE WENT TO 4.8 VOLTS COULDN'T FEEL ANYTHING. IN (B)(6), THE REP REPROGRAMMED HIM TO PROGRAM 2 AT 5.0 VOLTS. THEN THEY INCREASED TO 6.0 VOLTS. HE SAID HE JUST CHECKED HIS DEVICE AND IT CHANGED TO PROGRAM 3 FROM 2 ON ITS OWN. PT'S STATUS WAS REPORTED AS FAIR. PT WAS TO BE CONTACTED AND A DATE SCHEDULED FOR HIM TO BE SEEN IN THE OFFICE. ADD'L INFO HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM EZW MDT PUERTO RICO OPERATIONS CO., JUNCOS 3023 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 3095, LOT# NAH047175V| EXPLANTED:| LEAD: MODEL 3889, LOT# V386949| PROGRAMMER: MODEL 3037, LOT# NJD102852N| IMPLANTED: