BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 3243548 · Received July 23, 2013

    Report

    Report Number
    3004209178-2013-12197
    Event Type
    Injury
    Date Received
    July 23, 2013
    Report Date
    July 15, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37754, SERIAL# (B)(4). PRODUCT TYPE: RECHARGER: PRODUCT ID 37744, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 3777-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. PRODUCT TYPE: LEAD: PRODUCT ID 3777-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. PRODUCT TYPE: LEAD: PRODUCT ID 37754, SERIAL# (B)(4). PRODUCT TYPE: RECHARGER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RECHARGER SCREEN WAS UNRESPONSIVE AND IT WAS SUSPECTED THAT THE IMPLANTED DEVICE WAS OVERDISCHARGED. IT WAS NOTED THAT THE PATIENT HAD NOT CHARGED IN 3 MONTHS PRIOR TO THE REPORT AND STOPPED FEELING STIMULATION ABOUT 3 MONTHS PRIOR TO THE REPORT. IT WAS ALSO NOTED THAT IN THE PAST IT WOULD TAKE 6 HOURS TO FULLY CHARGE. A MANUFACTURE REPRESENTATIVE REPORTEDLY TRIED TO START THE PATIENT¿S DEVICE WITH THE REPRESENTATIVE¿S RECHARGER AND THE PATIENT¿S RECHARGE AND BOTH DID NOT WORK. THE REPRESENTATIVE ALSO REPORTEDLY TRIED TO TRICKLE CHARGE THE PATIENT¿S DEVICE AND THAT WOULD NOT WORK. THE REPRESENTATIVE WAS CONTACTED AND REPORTED THAT THE RECHARGER SCREEN WAS BLANK AND WOULD NOT CONNECT. THE REPRESENTATIVE WAS CONCERNED THAT THE IMPLANTED DEVICE MAY BE DEPLETED AND THAT THIS MAY NOT BE THE FIRST OVERDISCHARGE. ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT HAD THEIR IMPLANTABLE NEUROSTIMULATOR (INS) AND LEAD REPLACED TWO WEEKS PRIOR TO THE REPORT. THE REPORTER STATED THE INS COULD NOT BE RECHARGED 3 MONTHS AGO. ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT¿S INS WAS REPLACED DUE TO THE PATIENT NOT RECHARGING THEIR INS.

    Description of Event or Problem · 1

    IT WAS REPORTED ONE OF THE PATIENT¿S LEADS WENT BAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342608 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 Required Intervention