BEUDAMED
    FDA Adverse Event Death Summary report: N

    INTERSTIM II

    MDR report key: 3486291 · Received November 25, 2013

    Report

    Report Number
    3004209178-2013-21348
    Event Type
    Death
    Date Received
    November 25, 2013
    Date of Event
    June 7, 2013
    Report Date
    October 31, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION INDICATED THAT THE PATIENT¿S SYMPTOMS, REPORTED DEVICE ISSUES, AND DEATH WERE NOT RELATED TO THE DEVICE. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 3 093-28, LOT# V800436, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT DIED ON (B)(6) 2013 DUE TO ¿ACID LEAKAGE AND PARKINSON¿S.¿ IT WAS STATED THE PATIENT HAD PARKINSON¿S STAGE THREE AND THEY FELL DOWN THE STAIRS WHILE WALKING THEIR DOG AND THE PATIENT WENT TO A REHAB FACILITY AFTER THE FALL. THE PATIENT DID NOT DO HER LEG EXERCISES AT THE REHAB FACILITY, SO HER LEGS ¿ATROPHIED¿ AND SHE COULD NOT GET OUT OF BED. BY LYING IN BED SHE BECAME STIFF FROM PARKINSON¿S AND LOST WEIGHT FROM NOT EATING AND HAVING A POOR APPETITE. IT WAS STATED THE BATTERY PACKS THAT WERE IN HER, ¿THE ACID STARTED LEAKING AND CREATED HOLES IN HER KIDNEYS.¿ WHEN THE PATIENT FELL IN 2013, SHE WEIGHED (B)(6) POUNDS AND AT HER DEATH IN (B)(6) 2013, SHE WEIGHED (B)(6) POUNDS. THE CALLER WANTED TO DONATE THE PROGRAMMER.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT PER THE CORONER¿S OFFICE THE PRIMARY CAUSE OF DEATH WAS PARKINSON¿S DISEASE. IT WAS NOTED THAT NO AUTOPSY WAS PERFORMED. IT WAS LATER REPORTED THAT A HEALTHCARE PROVIDER VERIFIED THAT THE PRIMARY CAUSE OF DEATH WAS PARKINSON¿S DISEASE. THE HEALTHCARE PROVIDER REPORTED THAT THE ACID THAT WAS MENTIONED WAS ¿NOT FROM THE BATTERY OF ANY DEVICE.¿ IT WAS NOTED THAT THE PATIENT HAD POOR CIRCULATION BECAUSE THEY WERE NOT EATING, DRINKING, OR MOVING AND THAT WAS CAUSING FLUID BUILD-UP ISSUES. THE HEALTHCARE PROVIDER STATED THAT THIS HAD ¿NOTHING TO DO WITH THE DEVICE AT ALL.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612560 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR Death