BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE

    MDR report key: 3961579 · Received July 28, 2014

    Report

    Report Number
    3004209178-2014-13595
    Event Type
    Injury
    Date Received
    July 28, 2014
    Report Date
    July 2, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 377760, LOT# V002341, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD; PRODUCT ID 377760, LOT# V001708, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD; PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: RECHARGER; PRODUCT ID 377760, LOT# V002341, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD; PRODUCT ID 377760, LOT# V001708, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD; PRODUCT ID 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 377760, LOT# V001708, IMPLANTED: (B)(6) 2006, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD.

    Description of Event or Problem · 1

    MANUFACTURER RECORDS INDICATED THE LEAD THAT WAS EXPLANTED WAS THE LEAD WITH LOT NUMBER V001708.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. IT WAS NOTED THAT THE ELECTRODE IMPEDANCES ON THE RIGHT LEAD WERE GREATER THAN 3600 OHMS. IT WAS NOTED THAT THE IMPEDANCES ON THE LEFT LEAD WERE OKAY. IT WAS NOTED THAT THE PATIENT DID NOT HAVE THE SAME COVERAGE AS BEFORE AND THE PATIENT NEEDED TO INCREASE THE VOLTAGE ABOUT TWICE AS HIGH TO MAINTAIN THE STIMULATION COVERAGE. IT WAS NOTED THAT THIS SEEMED TO START AFTER THE PATIENT HAD A BACK MASSAGE AT THE END OF (B)(6) 2014. IT WAS NOTED THAT IT WAS NOT SUDDEN, BUT IT SEEMED TO BE RIGHT AFTER THE MASSAGE THAT THE PROBLEMS STARTED AND THEY CONTINUED TO GET WORSE. IT WAS NOTED THAT THE MANUFACTURING REPRESENTATIVE REPROGRAMMED FOR THE LEFT LEAD ONLY AND WAS GETTING OKAY COVERAGE. IT WAS NOTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS NEAR THE ESTIMATED REPLACEMENT INDICATOR (ERI). IT WAS FURTHER REPORTED THAT THE PATIENT WAS GETTING GROIN STIMULATION POSSIBLY DUE TO THE ISSUE WITH THE RIGHT LEAD. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS SCHEDULED FOR A BATTERY AND RIGHT LEAD REPLACEMENT FOR (B)(6) 2014. IT WAS NOTED THAT THE BATTERY WAS NEARING END OF LIFE (EOL) IN (B)(6).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT¿S REPLACEMENT SURGERY WENT VERY WELL. ONE OF THE PATIENT¿S LEADS AND HIS BATTERY WERE REPLACED. THE OLD LEAD WAS REMOVED AND THE NEW LEAD WAS PLACED IN THE SAME AREA, WHICH PROVIDED THE PATIENT WITH EXCELLENT COVERAGE. THE PATIENT WAS SEEN THE WEEK PRIOR TO THE REPORT AT HIS POST-OPERATIVE VISIT AND WAS VERY PLEASED WITH THE OUTCOME OF HIS SURGERY.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT PRIOR TO THE INS REPLACEMENT (B)(6) 2014, THE STIMULATOR "STARTED ACTING UP." IT WAS CLARIFIED THAT THE PATIENT WAS NOT GETTING AS GOOD PAIN COVERAGE AND IT WAS REPORTEDLY DISCOVERED BY THE HEALTHCARE PROVIDER, APPROXIMATELY FOUR WEEKS PRIOR TO THE REVISION, THAT ONE OF THE LEADS WASN'T FUNCTIONING PROPERLY AND THAT THE BATTERY WAS NOT COMMUNICATING PROPERLY WITH THE DEVICE, INDICATING THAT IT NEEDED TO BE REPLACED. IT WAS FURTHER REPORTED THE INS REACHED NORMAL END OF BATTERY SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439229 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 00045 YR Required Intervention