BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED

    MDR report key: 4129318 · Received September 30, 2014

    Report

    Report Number
    3004209178-2014-17959
    Event Type
    Injury
    Date Received
    September 30, 2014
    Report Date
    September 8, 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
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37083-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3998, LOT# V113343, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID: 37083-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: RECHARGER. PRODUCT ID: 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE PATIENT HAD HER INS REPLACED ON (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT LOST STIMULATION A COUPLE OF DAYS AGO. THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS DISCHARGED AND REPORTEDLY DIED 3 DAYS AGO. THE PATIENT HAS BEEN IN PAIN SINCE HER STIMULATOR WENT OUT, AND EXPERIENCED PAIN AT THE DEVICE POCKET. A COMMUNICATION PROBLEM WAS REPORTED. THE PATIENT HAD NOT BEEN ABLE TO CONNECT TO THE RECHARGER FOR THE PAST 3 DAYS AND WAS HAVING TROUBLE RECHARGING THE IMPLANTABLE NEUROSTIMULATOR (INS). SHE COULD GET THE RECHARGING SCREEN TO APPEAR BUT ALL THEY BOXES WERE WHITE. THE MANUFACTURER REPRESENTATIVE (REP) COULD NOT READ THE PATIENT¿S BATTERY. THE RECHARGER WAS CHARGING UP, AND THE LAST FULL CHARGE WAS ON (B)(6) 2014. THE PATIENT USES HIGH AMPLITUDE FOR STIMULATION AND RECHARGES EVERY DAY. THE PATIENT HAD REPORTEDLY LOST A CONSIDERABLE AMOUNT OF WEIGHT SINCE IMPLANT AND BELIEVED THE INS MAY BE FLIPPED. NO DIAGNOSTIC TESTING/TROUBLESHOOTING HAD BEEN PERFORMED BUT WOULD BE IN THE FUTURE. THE PATIENT WAS BEING REFERRED FOR AN X-RAY TO RULE OUT A FLIPPED GENERATOR. THE CAUSE OF THE PRODUCT ISSUE WAS NOT DETERMINED AND THE PRODUCT ISSUE WAS NOT RESOLVED. THE PATIENT¿S STATUS WAS NOTED TO BE ALIVE WITH NO INJURY. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL FOLLOW-UP IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609518 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37713

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR Required Intervention