BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3013412 · Received March 20, 2013

    Report

    Report Number
    3004209178-2013-04000
    Event Type
    Injury
    Date Received
    March 20, 2013
    Report Date
    March 5, 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
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3889-28, LOT # V995583, 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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT¿S DEVICE WORKED THE FIRST WEEK. HOWEVER, THE PATIENT WAS THEN ADJUSTED AND SHE HAD PROBLEMS EVER SINCE. THE PATIENT STATED THAT SHE WAS ¿SHOCKED INSTEAD OF GETTING AN IMPULSE.¿ THE PATIENT SAID THE DEVICE ¿WOULD SHOCK¿ HER IN HER BLADDER OR COLON AND THIS HAPPENED ¿ALL DAY UNTIL THE DEVICE CAME OUT.¿ THE PATIENT STATED THAT A MANUFACTURE REPRESENTATIVE CAME TO HER HOUSE TO DO ADJUSTMENTS WHEN SHE WAS TOLD THAT THE DEVICE ¿WAS FLOATING ABOUT A MONTH AFTER SURGERY.¿ THE PATIENT THEN HAD THE INFECTION AND EROSION THAT WAS PREVIOUSLY REPORTED. THE PATIENT WENT TO HER HEALTH CARE PROVIDER (HCP) THE DAY BEFORE ¿IT POPPED OUT¿ AND IT HAD BEEN ¿MOVING FOR SIX MONTHS.¿ THE DEVICE ¿POPPED OUT¿ WHILE HER HCP WAS ON VACATION AND THE WOUND ¿GOT SEVERELY INFECTED.¿

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2013 NOTED THAT THE PATIENT DID RECEIVE PERIOPERATIVE ANTIBIOTICS. THE DATE OF ONSET OF THE INFECTION WAS 2 - 3 DAYS PRIOR TO EXPLANT. THE PATIENT DID NOT HAVE MENINGITIS. SIGNS AND SYMPTOMS OF INFECTION INCLUDED: REDNESS, SWELLING, DRAINAGE, AND INCISIONAL WOUND OPENING. THE LOCATION OF THE INFECTION WAS THE DEVICE POCKET AND A CULTURE WAS OBTAINED FROM THE DEVICE POCKET, ORGANISM UNKNOWN. TREATMENT FOR THE INFECTION WAS IV AND ORAL ANTIBIOTICS AND TOTAL DEVICE SYSTEM EXPLANT. THE PATIENT OUTCOME WAS INFECTION RESOLVED. OTHER INFORMATION OF IMPORTANCE: "NGB SECONDARY TO GSW" (NEUROGENIC BLADDER SECONDARY TO GUN SHOT WOUND). ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2013 NOTED THAT THE IMPLANT WAS REMOVED ABOUT 3 WEEKS AGO. PER THIS REPORTER, THE SURGERY LEFT A HOLE THE SIZE OF A MAN'S FIST. THE HEALTHCARE PROVIDER DIDN'T PACK IT. IT BLED FOR 3 DAYS AND SHE HAD TO PACK IT HERSELF. THE PATIENT THEN HAD TO GO TO TWO WOUND CLINICS FOR THEM TO SCRAPE AND CLEAN THE WOUND AND THEN CLOSE IT UP.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD AN INFECTION AND THE DEVICE WAS ERODING THROUGH THE SKIN. IT WAS STATED THE DEVICE "BUSTED AND WHITTLED ITS WAY OUT OF THEIR BODY LIKE AN ALIEN." IT WAS ADDED THAT THE "WIRES WERE COMING OUT OF THEIR BODY" AS WELL. IT WAS INDICATED THE DEVICE HAD BEEN INFECTED SINCE (B)(6) 2012 WHEN THE DEVICE WAS IMPLANTED. IT WAS NOTED THE PATIENT WAS NOT ABLE TO SIT AND THE SYSTEM "FULLY CAME THROUGH THEIR SKIN" THE PREVIOUS WEEK TO REPORT. IT WAS FURTHER STATED THAT "THIS THING HAD BEEN OUT OF THEIR BODY AND THEY WERE PACKED WITH GAUZE" AS OF THE DATE OF THIS REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116552 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00046 YR Required Intervention