BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE

    MDR report key: 4305772 · Received December 8, 2014

    Report

    Report Number
    3004209178-2014-22784
    Event Type
    Injury
    Date Received
    December 8, 2014
    Date of Event
    November 13, 2014
    Report Date
    December 8, 2017
    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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: : PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: RECHARGER. PRODUCT ID 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID 377775, LOT# V012741, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID 377775, LOT# V012668, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID 3708120, SERIAL# (B)(4), IMPLANTED: (B)(6)2007, PRODUCT TYPE: EXTENSION. PRODUCT ID 3708120, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: RECHARGER. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID 37752 (B)(4) IMPLANTED: (B)(6)2007, PRODUCT TYPE RECHARGER PRODUCT ID 37742 (B)(4) IMPLANTED: (B)(6)2007, PRODUCT TYPE: PROGRAMMER, PATIENT PRODUCT ID 377775 , LOT# V012741, IMPLANTED:(B)(6) 2007, PRODUCT TYPE :LEAD, PRODUCT ID: 377775, LOT# V012668, IMPLANTED:(B)(6)2007, PRODUCT TYPE: LEAD, PRODUCT ID: 3708120, (B)(4)IMPLANTED: (B)(6)2007, PRODUCT TYPE: EXTENSION, PRODUCT ID: 3708120, (B)(4), IMPLANTED: (B)(6)2007, PRODUCT TYPE: EXTENSION, PRODUCT ID: 37752, (B)(4), IMPLANTED: (B)(6)2007, PRODUCT TYPE: RECHARGER IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: RECHARGER. PRODUCT ID: 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 377775, LOT# V012741, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID: 377775, LOT# V012668, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID: 3708120, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708120, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR RECHARGER (INSR) WASN¿T WORKING AND THE PATIENT COULDN¿T CONNECT WITH THE INSR OR THE PATIENT PROGRAMMER (PP). A COMMUNICATION PROBLEM WAS REPORTED AND THE PATIENT WAS ONLY SEEING THE REPOSITION ANTENNA SCREEN. THE ISSUES BEGAN THE DAY PRIOR TO THE REPORT. THE LAST TIME THE PATIENT CHARGED WAS TWO YEARS PRIOR TO THE REPORT. THE PATIENT WAS NOT CURRENTLY FEELING STIMULATION. AN IMPLANTABLE NEUROSTIMULATOR (INS) OVERDISCHARGE WAS SUSPECTED. IT WAS REVIEWED THAT EVEN IF THE PATIENT WASN¿T USING THE DEVICE THEY BATTERY COULD STILL RUN LOW SO THEY STILL NEEDED TO CHARGE. THE PATIENT MET WITH THE MANUFACTURER¿S REPRESENTATIVE (REP) AND A FIRST OVERDISCHARGE WAS CONFIRMED. A PHYSICIAN MODE RECHARGE (PMR) WAS PERFORMED BUT IT DID NOT SUCCESSFULLY RESET THE DEVICE. NO DIAGNOSTIC TESTING OR TROUBLESHOOTING WAS PERFORMED. IT WAS UNKNOWN WHAT THE CAUSE OF THE ISSUE WAS OR IF IT WAS RESOLVED, BUT IT WAS ALSO REPORTED THAT THE PATIENT STOPPED CHARGING THE DEVICE FOR APPROXIMATELY ONE YEAR. THE PATIENT WANTED THE BATTERY REPLACED WITH A NON-RECHARGEABLE DEVICE. THE PATIENT WAS GOING TO BE REFERRED TO A NEW SURGEON SINCE HE PREVIOUS SURGEON DIED. NEITHER THE SURGEON NOT THE DATE HAD BEEN DETERMINED AT THIS TIME. IT WAS REPORTED THAT THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. AT THE TIME OF THE REPORT THE PATIENT WAS ALIVE WITH NO INJURY. 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.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT ON 2017-11-10. IT WAS REPORTED THAT THE PATIENT DID NOT USE THE INS AND IT HAD TO BE SURGICALLY REPLACED. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    791012 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention