BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 4093409 · Received September 16, 2014

    Report

    Report Number
    3004209178-2014-17114
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Report Date
    August 25, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Removal / Correction Number
    Z-0124-2014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37746, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37754, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 39565-65, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN OVERDISCHARGE (OD) WAS SUSPECTED. THE PATIENT WAS UNABLE TO CONNECT TO HIS RECHARGER. HE HAD LOST HIS PROGRAMMER BUT WHEN HE GOT THE REPLACEMENT, IT STATED HIS STIMULATOR WAS DEPLETED. THE PATIENT TRIED TO CHARGE BUT WAS NOT ABLE TO CONNECT. HE HAD NOT MADE A COMPLETE CHARGE FOR 30 DAYS. THE PATIENT MET WITH A COMPANY REPRESENTATIVE FOR A RESTART/PHYSICIAN MODE RECHARGE (PMR). TWO PMRS WERE ATTEMPTED IN THE OFFICE TO GET OUT OF OD. THE PATIENT WAS SENT HOME TO DO A PMR AS WELL. THE PATIENT DID AS SUCH, AND WAS ABLE TO CHARGE, BUT HAD A WARNING POWER ON RESET (POR) AND OVERSTIMULATION. THE COMPANY REPRESENTATIVE PLANNED TO SEE THE PATIENT TO RESOLVE THE ISSUE. ADDITIONAL INFORMATION ABOUT THE OUTCOME/RESOLUTION WAS REQUESTED. IF RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS FURTHER STATED THAT THE PATIENT HAD NOT BEEN COMPLIANT. NO ADDITIONAL INFORMATION WAS KNOWN BY THE COMPANY REPRESENTATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571291 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1 00025 YR