BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 4138192 · Received October 3, 2014

    Report

    Report Number
    3004209178-2014-18237
    Event Type
    Injury
    Date Received
    October 3, 2014
    Report Date
    September 12, 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
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3889-28, LOT# V151684, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THAT PATIENT WAS IN THE HOSPITAL WITH COMPLEX NEUROLOGICAL SYMPTOMS WITH POSSIBLE SEIZURE LIKE EVENTS ,METABOLIC ENCEPHALOPATHY, WAS A HISTORY ATRIAL FIBRILLATION WHICH MAY BE A FACTOR CONTRIBUTING TO SOME NEUROLOGICAL SEQUELAE. IT WAS ALSO REPORTED AS UNKNOWN FOR WHAT COMPONENTS WERE INVOLVED. THE CAUSE OF EVENT WAS NOT DETERMINED AND IT WAS NOTED AS UNKNOWN IF DEVICE RELATED. IT WAS NOTED THAT THE DEVICE WAS OFF AND PATIENT WAS UNAVAILABLE. THE PATIENT OUTCOME WAS REPORTED AS UNKNOWN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S DEVICE WAS TURNED OFF DUE TO DEVICE MALFUNCTION. THE PATIENT¿S HEALTH CARE PROVIDER (HCP) ORDERED AN MRI OF THE BRAIN FOR RIGHT SIDE WEAKNESS AND THEY HAD RECEIVED THE MRI GUIDELINES. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THAT PATIENT DID NOT HAVE RIGHT SIDED WEAKNESS. SHE WAS HAVING SEIZURES. HER DEVICE MALFUNCTIONED 2 YEARS PRIOR TO SEEING THE HEALTH CARE PROVIDER. IT WAS NOTED THAT PATIENT RECOVERED WITHOUT PERMANENT IMPAIRMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620456 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O