BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3182077 · Received June 21, 2013

    Report

    Report Number
    3004209178-2013-10704
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    November 7, 2012
    Report Date
    May 30, 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
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3093-28 LOT# V414167, IMPLANTED: 2011 (B)(4), EXPLANTED: 2013 (B)(6), PRODUCT TYPE LEAD PRODUCT ID: 3037 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF NEUROSTIMULATOR MODEL 3058, SERIAL # (B)(4) SHOWED NO ANOMALIES. ANALYSIS OF LEAD MODEL 3093-28 LOT # V414167 SHOWED NO SIGNIFICANT ANOMALIES. THE CONDUCTORS WERE CRUSHED AT THE 4 LOCATIONS OF SUSPECTED TOOL MARKS IN THE OUTER INSULATION. THE LEAD WAS STRETCHED AT THE #2 AND 3 ELECTRODES. THERE IS AN INTERMITTENT SHORT BETWEEN ELECTRODES #0, 2, AND 3 CIRCUITS ¿SUSPECTED¿ WHERE THE LEAD WAS STRETCHED AT THE # ELECTRODE (LIKELY DUE TO EXPLANT DAMAGE). THE CONTINUITY WAS ACCEPTABLE AND GOOD STABLE OUTPUT WAS SEEN.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD ¿SHOCKING PAIN¿ AND A ¿FOOT DROP.¿ THE ISSUES WERE WORSE WHEN THE DEVICE WAS ON AND STILL PRESENT WHEN IT WAS TURNED OFF. THE PATIENT WAS DOING GREAT AFTER THE INITIAL IMPLANT BUT STARTED GETTING THE PAIN ¿ABOUT A YEAR AND THREE MONTHS LATER.¿ THE PATIENT WENT TO A ¿NERVE DOCTOR¿ AND WAS INFORMED SHE HAD NERVE DAMAGE THAT WAS ¿PROBABLY¿ FROM THE DEVICE. THE PATIENT DEVICE WAS INTERROGATED AT AN ¿EARLIER DATE¿ AND ALL OF THE IMPEDANCES WERE WITHIN NORMAL LIMITS. THE PATIENT WAS REPORTEDLY REPROGRAMMED. THE PATIENT¿S SYMPTOMS WERE A BURNING SENSATION, PAIN, AND SWELLING IN HER FOOT AND LEG. SINCE THE PATIENT STILL HAD THE PROBLEM WHEN THE DEVICE WAS TURNED OFF, THE HEALTH CARE PROVIDER (HCP) AND PATIENT DECIDED IT WAS BEST TO REMOVE THE IMPLANT. LATER THAT DAY, IT WAS REPORTED THAT THE LEAD AND STIMULATOR WERE EXPLANTED. FOUR DAYS LATER, IT WAS REPORTED THAT THE PATIENT OUTCOME WAS NOT KNOWN BUT THE DEVICE WAS SUCCESSFULLY EXPLANTED. THE FOLLOWING DAY, IT WAS REPORTED THAT THE PATIENT STATED, SHE WAS NOT HAVING ¿CORRECT STIMULATION.¿ THE LEAD APPEARED LATERAL AND DEEP AFTER PATIENT HAD ACCIDENT. THERE WAS LEAD DISLODGEMENT. THERE WAS NO PATIENT DEATH OR INJURY AND SHE RECOVERED WITHOUT SEQUELA. TWO DAYS LATER, IT WAS REPORTED THAT THE PATIENT¿S DEVICE WAS REMOVED BECAUSE, IT ¿MALFUNCTIONED¿ AND SHE WAS TREATED FOR LEG NERVE DAMAGE. THE HCP TOOK PICTURES OF THE LEAD AND STATED THAT SHE HAD ¿NEVER SEEN A LEAD SO BENT BEFORE.¿ THE PATIENT STATED THAT SINCE IMPLANT, SHE EXPERIENCED LEG PAIN AND SUFFERED GREATLY FROM NERVE DAMAGE. THE PATIENT STATED THAT THE LEAD ¿WENT DOWN ONE LEG¿ AND IT WAS HER LEFT LEG AND FOOT THAT WERE AFFECTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTS SHE HAD A FAULTY DEVICE THAT WAS TAKEN OUT (B)(6) 2013. SHE HAD DEVICE REMOVED BECAUSE SHE WAS EXPERIENCING ALL KIND OF PAIN. ALL OF A SUDDEN THE PATIENT WAS HAVING PAIN SHOOTING DOWN THE LEG. THE PATIENT ENDED UP WITH NERVE DAMAGE AND FEET WERE CONTRACTING. SHE WAS NOT HAVING AS MUCH PAIN NOW THAT THE DEVICE WAS OUT, BUT PAIN WAS BEING CONTROLLED BY AN EPIDURAL. THE PATIENT HAD PROBLEMS ABOUT 3 MONTHS AFTER IMPLANT. SHE WENT TO A FOOT AND LEG DOCTOR AND THEY FOUND OUT THE PAIN WAS DUE TO THE STIMULATOR. DOCTOR DID A FLUOROSCOPE AND FOUND THE LEAD WAS BENT. SHE CANNOT BARELY WALK ANYMORE AND NEEDS AN EPIDURAL. THE PATIENT STATES THERE WERE TOOLS MARKS ON THE LEAD AND IT WAS BENT. THE PATIENT WAS REQUESTING THAT THE DEVICE SHOULD BE RETURNED TO HER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283549 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00042 YR Other| R