BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2857016 · Received December 4, 2012

    Report

    Report Number
    3004209178-2012-11163
    Event Type
    Injury
    Date Received
    December 4, 2012
    Report Date
    November 9, 2012
    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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3777-75,SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37744, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3708260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION; PRODUCT ID 3487A-45, LOT# V845046, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3487A-45, LOT# V822013, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 3550-39 LOT#, PRODUCT TYPE ACCESSORY. ANALYSIS OF THE LEAD (S/N: (B)(4)) FOUND NO ANOMALY. ANALYSIS OF THE LEAD (LOT #: V845046) FOUND NO ANOMALY. ANALYSIS OF THE LEAD (LOT #: V822013) FOUND NO ANOMALY. ANALYSIS OF THE EXTENSION FOUND NO SIGNIFICANT ANOMALY. IT WAS STATED THE BODY WAS CUT THROUGH AND THE PRODUCT WAS SEGMENTED. ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (INS) FOUND NO SIGNIFICANT ANOMALY. IT WAS STATED THE INS WAS FUNCTIONALLY OKAY WITH INSIGNIFICANT ANOMALIES. ANALYSIS OF THE TITAN ANCHOR FOUND NO ANOMALY.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT NEVER HAD THERAPEUTIC EFFECT. SHE WAS FEELING INCREASED PAIN, SPASMS, AND LESS THAN 50% THERAPY RELIEF IN HER NECK. IT WAS STATED THAT AN X-RAY SHOWED A LEAD MIGRATION. IT WAS NOTED THAT HER IMPLANTING PHYSICIAN SUGGESTED EITHER A REVISION OR EXPLANATION OF THE LEAD; HOWEVER, NO DATE FOR INTERVENTION WAS SCHEDULED AT THE TIME OF REPORT. TEN DAYS LATER, IT WAS REPORTED THAT NO DATE HAD BEEN SCHEDULED FOR SURGERY YET. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE MADE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS), AND EXTENSIONS WERE EXPLANTED. IT WAS STATED THAT THERE WAS A LOSS OF THERAPEUTIC EFFECT, AND AN EXPLANT WAS REQUESTED BY THE PATIENT WHO WAS "UNABLE TO TOLERATE THE IMPLANT." IT WAS NOTED THAT THERE WAS NO NORMAL BATTERY DEPLETION. THERE WAS NO PATIENT DEATH. NO FURTHER INFORMATION WAS GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 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 Required Intervention