BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE

    MDR report key: 2094007 · Received May 13, 2011

    Report

    Report Number
    3004209178-2011-03493
    Event Type
    Injury
    Date Received
    May 13, 2011
    Date of Event
    February 2, 2009
    Report Date
    December 20, 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
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID 377860, LOT# V023021020, IMPLANTED: (B)(6) 2007; EXPLANTED: (B)(6) 2010; PRODUCT TYPE: LEAD. PRODUCT ID 3550-29, LOT# N0042729, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: ACCESSOR. PRODUCT ID 37742, SERIAL# (B)(4); IMPLANTED: (B)(6) 2007; PRODUCT TYPE: PROGRAMMER. PATIENT 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT AND MULTIPLE AREAS OF PAIN. RETURN OF PAIN IN THE PATIENT'S BACK CAUSED NUMBNESS IN THE FOOT WHICH CAUSED THE PATIENT TO FALL AND BREAK AN ANKLE, WHICH LEAD TO HIP PAIN. IT WAS LATER REPORTED THAT THE DEVICE SYSTEM WAS EXPLANTED DUE TO LACK OF EFFECT CAUSED BY SCAR TISSUE THAT HAD GROWN DENSELY AROUND THE LEAD, AFFECTING THE STIMULATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). THE PATIENT REPORTED A LOSS OF THERAPEUTIC EFFECT. THE PATIENT REPORTED THAT SHE HAD MULTIPLE AREAS OF PAIN THAT WERE LIKELY RELATED TO EACH OTHER. THE PATIENT REPORTED PAIN IN HER BACK CAUSED NUMBED IN FOOT WHICH CAUSED HER TO FALL AND BREAK HER ANKLE. THE PATIENT REPORTED THAT THE BROKEN ANKLE CAUSED HER TO WALK IN A MANNER THAT AFFECTED HER HIP AND SHE NOW HAD PAIN IN HER BACK, FOOT, ANKLE AND HIP. ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT ON 2011-04-15. THE PATIENT REPORTED THAT SHE HAD THE SYSTEM REMOVED ON (B)(6) 2010. THE PATIENT REPORTED THAT THE SYSTEM WASN¿T WORKING BECAUSE THEY HAD SCAR TISSUE THAT HAD GROWN DENSELY AROUND THE LEAD, SO STIMULATION WASN¿T GOING FAR ENOUGH TO HELP WITH THE PAIN. ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT ON 2017-11-21. THE PATIENT REPORTED THAT SCAR TISSUE GREW ON THE LEADS, SO THE PULSATION WASN¿T GOING THROUGH, SO IT WAS SWITCHED OUT AFTER 3 YEARS. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention EXPLANTED:| IMPLANTED:| IMPLANTED:| LEAD: MODEL 3778, LOT# V023021020| STIM ACCESSORY: MODEL 3550-29, LOT# N0042729| PROGRAMMER: MODEL 37742, LOT# NJD045793N| ACCESSORY: MODEL 37752, LOT# NKA029418N| EXPLANTED: