BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 2926527 · Received January 23, 2013

    Report

    Report Number
    6000032-2013-00018
    Event Type
    Malfunction
    Date Received
    January 23, 2013
    Report Date
    January 3, 2013
    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
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3095-10, SERIAL# (B)(4), IMPLANTED: (B)(6) 2002, EXPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION; PRODUCT ID 3093-28, LOT# J0228130V, IMPLANTED: (B)(6) 2002, EXPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3031A, SERIAL# (B)(4), IMPLANTED: (B)(6) 2002, PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION RECEIVED REPORTED THAT THE CAUSE OF THE EVENT WAS THE PATIENT'S CONCOMITANT ISSUES OF MERCURY POISONING AND LYME'S DISEASE. IT WAS NOTED THAT THE "UNUSUAL SYMPTOMS" THE PATIENT EXPERIENCED OCCURRED WHEN THE LYME'S DISEASE FLARED UP AND WAS BELIEVED WHAT THE PATIENT EXPERIENCED WAS MOST LIKELY DUE TO THEIR PREVIOUS HISTORY. THE PATIENT WAS REFERRED BACK TO THEIR PAIN NEUROLOGIST.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD 'SEVERAL ISSUES' AND HAD REPORTED 'SEVERAL ADVERSE EVENTS' TO HIS HEALTHCARE PROVIDER (HCP) OVER THE YEARS. THE PATIENT WENT TO SEE HIS HCP WITH A HISTORY OF MERCURY POISONING THAT RENDERED HIM DISABLED. PATIENT ALSO DEVELOPED LYME DISEASE WHILE HE WAS IMPLANTED. THE REPORTER STATED THAT THEY USED TO HAVE THE PATIENT LAY ON HIS STOMACH TO BE PROGRAMMED AND EVEN AT 0 V, HE WOULD 'HIT THE CEILING.' THE PATIENT WAS REPORTED TO HAVE 'FELT STIMULATION EVEN WHEN THERE WAS NO REASON TO FEEL STIMULATION.' THE PATIENT ALSO FELT STIMULATION IN HIS UPPER RIBCAGE AND BILATERALLY IN HIS LEGS. THE REPORTER INDICATED THAT EVERY TIME THE PATIENT WENT TO GET THE MAIL BY HIS DOG'S WIRELESS FENCE, 'IT TOOK HIM TO HIS KNEES.' THE PATIENT ALSO REPORTEDLY WENT TO THE BATHROOM 75 TIMES PER DAY. THE REPORTER STATED THAT IT MIGHT HAVE BEEN A 'BIO-PHYSICAL ISSUE' WITH THE PATIENT AND FELT THAT HIS NERVE CONDUCTION PATHWAYS MIGHT HAVE BEEN 'ABNORMAL' DUE TO MEDICAL ILLNESSES. IT WAS INDICATED THAT THE REPORTER WAS GOING TO SPEAK WITH MEDTRONIC REPRESENTATIVES THE FOLLOWING WEEK TO GET FEEDBACK ON WHAT WAS GOING ON. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32928 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MDT SOFAMOR DANEK PUERTO RICO MFG 3023

    Patients

    Seq Age Sex Outcome Treatment
    1