BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 3790830 · Received May 5, 2014

    Report

    Report Number
    3004209178-2014-08528
    Event Type
    Injury
    Date Received
    May 5, 2014
    Report Date
    April 10, 2014
    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
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3037, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3095-10, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE EXTENSION; PRODUCT ID 3889-28, LOT # V182143, IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 3889-28, LOT # V178924, IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 3095-10, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE EXTENSION; PRODUCT ID 3037, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3889-28, LOT # V178924, IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    UPON DEVICE RETURN, ANALYSIS FINDING FOR STIMULATOR SERIAL NUMBER (B)(4) FOUND NORMAL END OF LIFE, NO TELEMETRY AND NO OUTPUT. THE BATTERY EPOXY BOND BROKEN FOR BOTH B POSITIVE AND B NEGATIVE. DESTRUCTIVE ANALYSIS OF THE BATTERY WAS NOT NECESSARY PER DESIGN HISTORY DOCUMENT. NO SYSTEM TEST DONE AS STIMULATOR HAD NO TELEMETRY. THE STIMULATOR WAS DISCONNECTED AND PROXIMAL SEGMENT OF EXTENSION FUNCTIONALLY TESTED. ANALYSIS FINDING FOR THE LEAD SERIAL NUMBER (B)(4) FOUND DISTAL END CONDUCTOR WAS BROKEN. THE FUNCTIONAL TEST OF DISTAL END WAS CONTINUITY ACCEPTABLE CIRCUITS AT 0-2. OPEN CIRCUIT WAS NOTED ON 3. BROKEN CONDUCTOR ON NUMBER 3 AT THE NUMBER 3 ELECTRODE WELD SIDE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS FEELING SHARP PAIN AT BOTH THEIR STIMULATOR SITES. THE PATIENT STATES THAT THEIR LEFT STIMULATOR THAT THEY TOUCHED 3-4 DAYS AGO AND "PUSS CAME OUT" AND IT WAS SORE TO THE TOUCH. THE PATIENT TOUCHED STIMULATOR SITE ON LEFT THE DAY OF REPORTED EVENT DATE AND PUSS CAME OUT AGAIN. THE PATIENT WAS SORE TO THE TOUCH ON THE REPORTED EVENT DATE. THE PATIENT STATES THERE WAS A "BLACK HOLE" ON THE LEFT STIMULATOR SITE WHERE THE PUSS CAME OUT. THE PATIENT CALLED THEIR HEALTHCARE PROVIDER THE MORNING OF REPORTED EVENT DATE. THE PATIENT STATES THAT A FEW DAYS AGO THEY FELT SHARP PAIN AND WAS ABLE TO TURN THEIR STIMULATION DOWN ON THE LEFT SIDE. IT WAS NOTED DURING THE CALL THAT THE PATIENT TRIED TO CONNECT PROGRAMMER TO THEIR STIMULATOR BUT THEIR HEALTHCARE PROVIDER OFFICE CALLED SO THEY NEEDED TO DISCONNECT. FOLLOW UP INFORMATION ONE DAY LATER REPORTED THAT THE DEVICE WAS EXPLANTED. THE PATIENT REPORTED SHOCKING/JOLTING SENSATION. IMPEDANCE TESTING WAS PERFORMED. IT WAS REPORTED THAT THE BATTERY HAD PREMATURE DEPLETION. THE PATIENT CALLED HEALTHCARE PROVIDER AND COMPLAINED THAT THEIR INTERSTIM SHOCKED THEM VERY BAD A BLEW A HOLE IN THEIR SKIN. HEALTHCARE PROVIDER INSTRUCTED THE PATIENT TO HIS OFFICE IMMEDIATELY. HE LOOKED AT THE SITE AND DETERMINED THERE WAS A HOLE IN THE PATIENTS SKIN "LATERAL" TO THE BATTERY. THE HEALTHCARE PROVIDER SCHEDULED AN EMERGENCY EXPLANT FOR THE NEXT DAY. THEY TRIED TO INTERROGATE THE BATTERY BUT GOT NO RESPONSE. THE BATTERY WAS RELATIVELY NEW THEREFORE SHOULD HAVE ENERGY LEFT. THE SKIN WAS BRUISED AROUND THE PUNCTURE HOLE. HEALTHCARE PROVIDER OPENED THE POCKET SITE AND NOTICED THE LEAD CONNECTION SITE MIGRATED TO THE SURFACE OF THE SKIN AND WAS EXPOSED THROUGH THE HOLE IN THE PATIENTS SKIN. HIS ASSUMPTION WAS THE LEAD WAS VERY CLOSE TO THE SURFACE OF THE SKIN AND CONDUCTED CAUSING AN ELECTRICAL SHOCK AND EXIT WOUND THROUGH THE SKIN. ALL PARTS WERE SUCCESSFULLY IMPLANTED. THE PATIENT WAS REPORTED AS ALIVE WITH INJURY AS THE DATE OF THE REPORTED EVENT. EXIT WOUND IN THE SKIN LATERAL TO THE BATTERY. THE BATTERY STOPPED WORKING. THE PATIENT SYMPTOMS ASSOCIATED WITH THIS EVENT WERE BURNING SENSATION, EROSION AND INFECTION (UNKNOWN TYPE OF INFECTION) AND IT WAS UNKNOWN IF CULTURE WAS TAKEN. ANTIBIOTIC TREATMENT WAS NECESSARY. THE LOCATION OF THE PATIENT SYMPTOM WAS AT THE DEVICE POCKET. THEPATIENT EXPERIENCED A SHOCK AND INJURY TO POCKET SITE. ADDITIONAL INFORMATION RECEIVED REPORTED THERE WAS NOT ADDITIONAL INTERVENTIONS TAKEN OR PLANNED. THE OUTCOME OF THE PATIENT WAS REPORTED AS THE PATIENT STILL HAVE THE ONE IMPLANT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED NOTED THAT THE PATIENT HAD A 3023 THEREFORE THE CONNECTION SITE REFERRED TO IS WHERE THE LEAD CONNECTS TO THE EXTENSION. THE CONNECTION SITE MIGRATED TO THE SKIN SURFACE. THE LEAD WAS PLACED PROPERLY. THE COMPLETE SYSTEM WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266336 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3023

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Required Intervention