BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESCAN

    MDR report key: 4221036 · Received November 3, 2014

    Report

    Report Number
    3004209178-2014-20856
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    October 13, 2014
    Report Date
    October 13, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    GZB
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3550-29, LOT# N471002, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 97740, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT HEALTH CARE PROVIDER (HCP) CONFIRMED THERE WAS A 50% OR GREATER SYMPTOM REDUCTION. THE CAUSE OF THE EVENT WAS DETERMINED AND WAS NOT DEVICE RELATED. REPROGRAMMING WAS NOT NEEDED. THE PATIENT DID NOT EXPERIENCE A LOSS OF THERAPEUTIC EFFECT BUT DID EXPERIENCE A SUDDEN LOSS OF STIMULATION. THE PATIENT DID NOT REALIZE HOW TO TURN THE MACHINE ON. THE PATIENT HAS RECOVERED WITHOUT PERMANENT IMPAIRMENT.

    Description of Event or Problem · 1

    THE PATIENT COMPLAINED OF VIBRATION AND WAS ADMITTED TO THE HOSPITAL TODAY WITH SEVERE PAIN. THE PATIENT WANTED TO HAVE A COMPANY REPRESENTATIVE PAGED TO SHUT OFF THE DEVICE. THE PATIENT BROUGHT THE PATIENT PROGRAMMER (PP) TO THE HOSPITAL. UPON INTERROGATION, THE STIMULATION OFF ICON DISPLAYED. DURING THE REPORT, THE REPORTER TURNED THE DEVICE ON AND OFF TO VERIFY THE OFF SETTING. AFTER THE REPORTER TURNED THE STIMULATION OFF, THE PATIENT STATED THAT THE VIBRATING TURNED OFF. THE PAIN REMAINED AFTER TURNING THE DEVICE OFF. ADDITIONAL INFORMATION HAS BEEN REQUESTED TO FIND OUT IF ANY TROUBLESHOOTING OR INTERVENTION WAS REQUIRED AND TO OBTAIN THE OUTCOME OF THIS EVENT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703073 SURESCAN STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) GZB MEDTRONIC PUERTO RICO OPERATIONS CO. 97702

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Hospitalization