BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2931354 · Received January 28, 2013

    Report

    Report Number
    3004209178-2013-01032
    Event Type
    Injury
    Date Received
    January 28, 2013
    Report Date
    January 8, 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
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3889-28, LOT# VA01JEF, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS OF THE DEVICE, SERIAL #(B)(4), FOUND NO ANOMALY. ANALYSIS OF THE LEAD, LOT #VA01JEF, FOUND THE BODY CUT THROUGH AND SEGMENTED. THERE WAS NO SIGNIFICANT ANOMALY.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE INS HAD NOT BEEN FUNCTIONING PROPERLY SINCE IMPLANT. THERE WAS PAIN AT THE INS INCISION SITE AND SHOCKING DOWN THE LEG. WHEN USING THE PROGRAMMER THE PATIENT EXPERIENCED SHOCKING WITH ANY CHANGES SHE MADE. IT WAS ALSO REPORTED THAT WHEN THE DEVICE WAS OFF THE PATIENT WAS STILL FEELING STIMULATION. THE DEVICE HAD BEEN OFF FOR A FEW MONTHS. THE PATIENT WAS REPROGRAMMED A FEW TIMES AND IT ONLY CAUSED HER MORE PAIN, AND THE PATIENT FELT THAT THE LEAD MAY BE IN THE WRONG PLACE OR THE INS WAS MALFUNCTIONING. IT WAS REPORTED THAT THE PATIENT WAS GETTING THE INS REMOVED ON (B)(6) 2013.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SHOCKING OR JOLTING SENSATION. THE PATIENT MET WITH HER HEALTHCARE PROVIDER (HCP) THE DAY BEFORE THE REPORT, AFTER HER DEVICE HAD BEEN OFF FOR TWO MONTHS. THE REPORTER STATED THAT THE PATIENT'S DEVICE WAS TURNED OFF BECAUSE THE HCP THOUGHT THAT THE PATIENT WAS 'HYPERSENSITIVE' TO STIMULATION. THE HCP DECIDED TO SWITCH THE PATIENT'S SETTINGS TO PROGRAM 2 AT 2.8V. WHEN THE PATIENT WENT HOME HOWEVER, STIMULATION WAS TOO STRONG. AS SUCH, THE PATIENT TURNED STIMULATION DOWN TWICE. HOWEVER, EACH TIME THE PATIENT TURNED STIMULATION DOWN, SHE FELT A JOLT. IT WAS NOTED THAT THE PATIENT HAD NEVER FELT SHOCKS FROM TURNING STIMULATION DOWN PREVIOUSLY. THE PATIENT EVEN GOT SHOCKED WHEN SHE JUST USED THE 'SYNCHRONIZE' FUNCTION. THE REPORTER INDICATED THAT THE PATIENT HAD FIBROMYALGIA AS WELL AS AUTONOMIC DYSFUNCTIONS. HOWEVER, THE SENSATION THAT THE PATIENT FELT FROM THE DEVICE WAS DIFFERENT FROM THE USUAL PAIN SHE HAD FROM FIBROMYALGIA. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE IMPLANTABLE NEUROSTIMULATOR AND LEAD WERE REMOVED ON (B)(6). THE "OP" NOTE STATED THE "LEAD WIRE WAS COILED AROUND SUBCUTANEOUS TISSUE." IT WAS INDICATED THE HEALTHCARE PROVIDER HAD TO CUT "ANOTHER AREA" BECAUSE THE LEAD WAS STUCK. THERE WAS ANOTHER INCISION MADE SO THE LEAD WIRE COULD BE REMOVED. IT WAS UNCLEAR HOW MANY LEADS THE PATIENT HAD. IT WAS INDICATED THAT THERE WAS "NO NORMAL" BATTERY DEPLETION AND THE PATIENT RECOVERED WITHOUT SEQUELA. ADDITIONAL REVIEW INDICATED THE EVENT ORIGINALLY REPORTED UNDER MANUFACTURER REPORT NUMBER 3004209178-2012-09430 REPORTED INFORMATION THAT PERTAINED TO THE EVENT REPORTED UNDER THIS MANUFACTURER REPORT NUMBER. BOTH REPORTS INDICATED THE PATIENT WAS EXPERIENCING SHOCKING, PAIN, FEELING STIMULATION WHILE THE DEVICE WAS OFF, AND A SUBSEQUENT EXPLANT. IT WAS UNCLEAR WHAT THE EXPLANT DATE WAS BECAUSE TWO DIFFERENT DATES WERE REPORTED. ANY ADDITIONAL INFORMATION RECEIVED WILL BE REPORTED UNDER THIS MANUFACTURER REPORT NUMBER.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT CLAIMED THE SHOCKING SENSATIONS WERE DUE TO AN AIRPORT SCANNER. NO INFECTIONS WERE SEEN AT THE INCISION SITE. THE CAUSE OF THE PATIENT'S PAIN WAS UNKNOWN. PATIENT HAD CHRONIC PAIN. IT WAS NOTED THE PATIENT WAS HISTRIONIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36973 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00036 YR Required Intervention