BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE

    MDR report key: 4221175 · Received November 3, 2014

    Report

    Report Number
    3004209178-2014-20860
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    October 12, 2014
    Report Date
    October 13, 2014
    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
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37711, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 3708360, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708360, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3487A, LOT# J0015934V, IMPLANTED: (B)(6) 2001, PRODUCT TYPE: LEAD. PRODUCT ID: 3487A, LOT# J0008033V, IMPLANTED: (B)(6) 2001, PRODUCT TYPE: LEAD. PRODUCT ID: 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE: RECHARGER. PRODUCT ID: FA37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3708360, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708360, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3487A, LOT# L48675, IMPLANTED: (B)(6) 1998, PRODUCT TYPE: LEAD. PRODUCT ID: 3487A, LOT# L47689, IMPLANTED: (B)(6) 1998, PRODUCT TYPE: LEAD. PRODUCT ID: 3487A, LOT# J0225356V, IMPLANTED: (B)(6) 2002, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED ABOUT 2 MONTHS LATER REPORTED THAT BOTH BATTERIES WERE REPLACED DUE TO NORMAL BATTERY DEPLETION. NO DEVICE MALFUNCTIONS WERE NOTICED. THE PATIENT HAD BEEN DOING FINE AFTER THAT. IT WAS NOTED THAT THE DEVICE WOULD NOT BE RETURNED. RECORDS SHOWED THAT THE REPLACEMENT TOOK PLACE ON (B)(6) 2014.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE TELEMETRY ISSUES. A MANUFACTURING REPRESENTATIVE MET WITH THE PATIENT AND WAS UNABLE TO GET COMMUNICATION WITH EITHER BATTERY. ¿BOTH OF THEM WENT OUT.¿ TWO DAYS PRIOR EVERYTHING WAS FINE. HOWEVER, THE DAY PRIOR EVERYTHING HAD JUST SHUT OFF. THE PHYSICIAN WAS GOING TO REPLACE BOTH BATTERIES ON (B)(6) 2014. NO OUTCOME WAS 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702653 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR Required Intervention