BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2882525 · Received December 20, 2012

    Report

    Report Number
    3004209178-2012-12127
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Report Date
    December 3, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3889-28, LOT# V855089, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. (B)(4).

    Description of Event or Problem · 1

    A LOSS OF THERAPEUTIC EFFECT WAS REPORTED. THE LOSS OF RELIEF WAS OBSERVED FOR ABOUT A WEEK. PATIENT'S INCONTINENCE WAS BACK. THE PATIENT HAD TROUBLE WITH COMMUNICATION THE DAY PRIOR TO THE REPORT. HOWEVER, WHEN SHE TRIED TO CONNECT WITH THE IMPLANTABLE NEUROSTIMULATOR (INS) ON THE DAY OF THE REPORT, SHE WAS ABLE TO CONNECT ON THE FIRST TRY. IT WAS REPORTED THAT THE PATIENT HAD STARTED FEELING THE STIMULATION AFTER SHE HAD CONNECTED. SHE USED THE ON THERAPY BUTTON TO SYNC. THE EVENT/SYMPTOMS OCCURRED FOLLOWING A FALL. PAIN ON HER LEFT HIP AT THE INS SITE FOR ABOUT A MONTH AFTER THE FALL WAS REPORTED. THE PATIENT FELL DOWN THE STAIRS AND SLID DOWN THE STAIRS ON HER BACK "LIKE ON A CARTOON." IT WAS STATED THAT THE PAIN WAS THERE ALL THE TIME AT THE INS SITE, AND AT FIRST, IT WAS THOUGHT TO BE ATTRIBUTED TO HER GENERAL BACK PAIN THAT SHE HAD HAD FOR A LONG TIME. THE PATIENT'S STATUS WAS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. WHEN RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1