BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 3935499 · Received July 15, 2014

    Report

    Report Number
    6000032-2014-00146
    Event Type
    Injury
    Date Received
    July 15, 2014
    Report Date
    June 23, 2014
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3031, SERIAL# (B)(4), IMPLANTED: (B)(6) 2000, PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 3080, LOT# L86580, IMPLANTED: (B)(6) 2000, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN 2003 THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) WAS ¿OVERPROGRAMMED AND BLEW OUT HER LEFT SIDE.¿ OMITTED INFORMATION RELATED TO OTHER MEDICAL ISSUES NOT ALLEGED TO BE DEVICE RELATED AND THEREFORE NON-COMPLAINTS. IT WAS LATER REPORTED THE PATIENT WAS ¿OVERPROGRAMMED¿ IN 2003 AND THEIR DEVICE ¿LOCKED LEFT SIDE OF BACK MUSCLE.¿ IT WAS STATED THAT DUE TO THREE MONTHS OF LEAVING THE IMPLANT ON A RATE OF ¿300 OPEN¿ THEY HAD AN INTERSTITIAL CYSTITIS FLARE IN 2003. IT WAS NOTED THE PATIENT COULD NOT PUT THEIR DEVICE UP OR THEIR ENTIRE VERTEBRAE LOCKS DOWN AND THEY HAD LEVEL 10 PAIN OCCUR. IT WAS STATED THE PATIENT MET WITH THEIR MANUFACTURER REPRESENTATIVE AND THEY DECREASED THE RATE AND CHANGED THEIR ¿LEAD FROM 3 TO 5 AND UPS MODULATION X10.¿ IT WAS NOTED THE PATIENT GOT IN THEIR CAR AND DROVE A BLOCK AND THE IMPLANTABLE NEUROSTIMULATOR (INS) TRIGGERED AND THEY ALMOST SMASHED INTO ANOTHER CAR. REPORTEDLY, THE PATIENT SWITCHED IT BACK TO THE ORIGINAL SETTING AND WENT TO A CHIROPRACTOR TO PUT THEIR VERTEBRAE BACK IN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413609 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MDT SOFAMOR DANEK PUERTO RICO MFG 3023

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention