BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3023901 · Received March 27, 2013

    Report

    Report Number
    3004209178-2013-04304
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Report Date
    March 11, 2013
    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
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3037, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3093-33, LOT # VA054Y5, IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED NO STIMULATION SENSATION. IT WAS STATED THAT ON (B)(6) 2013 THE PATIENT WAS "ON A MASSAGE CHAIR WITH ROLLERS AND ALSO AN EXERCISE MACHINE AND WHEN IT'S TURNED ON IT SHAKES THE WHOLE BODY." IT WAS REPORTED "THAT SET IT OFF". IT WAS NOTED THAT THE PATIENT HAD "BAD PAINS" IN THE PELVIC AREA AND IN THE BACK WHERE THE LEADS START. ALSO, THE PATIENT STOPPED FEELING STIMULATION. IT WAS REPORTED THAT THESE SYMPTOMS BEGAN ON (B)(6) 2013 WITH THE MASSAGE CHAIR. IT WAS STATED THAT THE PATIENT FELT PAIN WHETHER THE DEVICE WAS ON OR OFF. FURTHER INFORMATION HAS BEEN REQUESTED. IF MORE INFORMATION IS RECEIVED A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION RECEIVED REPORTED THAT THE PAIN WAS UNRELATED TO THE IMPLANTABLE NEUROSTIMULATOR (INS) OR THE LEAD COMPONENT. NO SURGICAL INTERVENTIONS WERE PERFORMED AS A RESULT OF THE EVENT. NO OTHER INFORMATION WAS PROVIDED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127332 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1