BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2931031 · Received January 28, 2013

    Report

    Report Number
    3004209178-2013-01024
    Event Type
    Injury
    Date Received
    January 28, 2013
    Date of Event
    November 24, 2012
    Report Date
    May 23, 2017
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 39565-30, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE EXTENSION; PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED PAIN AROUND THE IMPLANTABLE NEUROSTIMULATOR (INS) SITE. THE INS SITE WAS TENDER AND SENSITIVE TO THE TOUCH AND HAD BEEN LIKE THAT FOR THE PATIENT SINCE IMPLANT, AND IT WAS GETTING WORSE. IT WAS STATED THAT THE STIMULATOR WAS FUNCTIONING 'WELL' AND THERE WAS NO KNOWN CAUSE FOR THE PAIN. THE STIMULATION WAS TARGETING HER LEGS AND HIPS AND SHE HAD 'NO ISSUES WITH CHARGING OR THE FUNCTION OF THE INS.' ADDITIONAL INFORMATION FROM THE HEALTH CARE PROVIDER (HCP) REPORTED THAT THERE WAS NO KNOWN CAUSE OF THE EVENT AND THE PATIENT WAS NOT HOSPITALIZED. LATER IT WAS REPORTED THAT THE PATIENT STILL HAD CONCERNS REGARDING HER DEVICE OR THERAPY AND WAS GOING TO MEET WITH HER SURGEON ON (B)(6) 2012. ADDITIONAL INFORMATION RECEIVED FROM THE HCP REPORTED THAT THE CAUSE OF THE EVENT WAS STILL UNKNOWN. THERE WAS TENDERNESS AT THE INS SITE AND MOVEMENT WITHIN THE POCKET. THE INS WAS REPLACED AND REPOSITIONED. IT WAS STATED THAT RESULTS WERE 'GOOD.' HOSPITALIZATION WAS NOT REQUIRED AND THERE WAS NO PATIENT INJURY. NO FURTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE CONSUMER ON (B)(6) 2017 REPORTING THAT THE PATIENT¿S CURRENT IMPLANT WAS THEIR 3RD NOT THEIR 2ND. THE PATIENT THOUGHT THEIR FIRST IMPLANT WAS IN 2005 WHICH WAS NOT WHAT REGISTRATION SHOWED. REGISTRATION SHOWED 2007. DUE TO THIS, IT WAS NOTED THAT THE EVENT DATES WERE UNKNOWN. IT WAS STATED THAT ALL THE CONSUMER KNEW WAS THAT THEY HAD A TOTAL OF 4 SURGERIES RELATED TO THE DEVICE: THE FIRST WAS THE TRIAL INSERT, THE SECOND WAS THE ORIGINAL IMPLANT SURGERY, THE THIRD WAS DUE TO A DAMAGED LEAD, AND THE FOURTH WAS WHEN THE IMPLANT WAS MOVED TO A DIFFERENT LOCATION. (SEE MDR # 6000153-2008-02756 FOR THE LEAD DAMAGE SURGERY). SINCE THE BATTERY WAS SO LARGE, ¿AS BIG AS A DECK OF CARDS,¿ AND BECAUSE THE PATIENT WAS NOT A VERY BIG PERSON, THE DEVICE WAS CHANGED TO A SMALLER BATTERY AND PUT IN A DIFFERENT LOCATION DUE TO IT HURTING THE PATIENT. THE PAIN AT THE IMPLANT SITE WAS ORIGINALLY REPORTED TO BE IN 2009. IT WAS CLARIFIED THAT THE PATIENT WAS NOT SURE IF THE BATTERY WAS CHANGED OR IF IT WAS JUST MOVED TO A DIFFERENT LOCATION. IT WAS CLARIFIED THOUGH THAT THE PATIENT¿S CURRENT IMPLANT WAS SMALLER THAN THE FIRST SO IT WAS THOUGHT THAT THE HCP CHANGED THE BATTERY TOO. IT WAS STATED THAT THE CURRENT IMPLANT WORKED GREAT AND THE PATIENT HAD NOT BEEN HAVING ANY PROBLEMS WITH IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37268 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 54 YR Required Intervention