BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2925058 · Received January 22, 2013

    Report

    Report Number
    3004209178-2013-00816
    Event Type
    Injury
    Date Received
    January 22, 2013
    Report Date
    December 30, 2012
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR FOUND NO SIGNIFICANT ANOMALY. IT WAS NOTED THE BATTERY HAD REDUCED CAPACITY DUE TO OVERDISCHARGE.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3777-60, SERIAL# (B)(4), EXPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 3777-60, SERIAL# (B)(4), EXPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED A SHOCKING SENSATION. IT WAS STATED THE PATIENT HAD NOT USED THE DEVICE IN MORE THAN 10 MONTHS AND HAD NOT 'MAINTAINED CHARGING' AS WELL. THEN DEVICE WAS IN OVERDISCHARGE. THE PATIENT ALSO EXPERIENCED PAIN IN THEIR BACK. THE PATIENT'S STATUS WAS REPORTED AS NO INJURY AND NO ADVERSE EVENT. ABOUT THREE WEEKS LATER, THE PATIENT HAD STILL NOT HAD A PHYSICIAN RECHARGE MODE DONE TO RECOVER THE BATTERY. NO FURTHER INFORMATION WAS REPORTED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) SYSTEM WAS EXPLANTED. IT WAS NOTED THAT THE DEVICE WAS OVERDISCHARGED ¿MULTIPLE TIMES¿. THE PATIENT STATUS WAS REPORTED AS ALIVE WITH NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31256 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention