BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 4133479 · Received October 1, 2014

    Report

    Report Number
    3004209178-2014-18129
    Event Type
    Injury
    Date Received
    October 1, 2014
    Report Date
    September 9, 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
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (INS) FOUND NO SIGNIFICANT ANOMALY. THE INS BATTERY HAD REDUCED CAPACITY DUE TO OVERDISCHARGE. THE LAST RECHARGE SESSION OCCURRED ON (B)(6) 2013. THE NEXT ATTEMPT TO RECHARGE OCCURRED AT BENCH TESTING (B)(6) 2014.

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3998, LOT# V855145, IMPLANTED: 2011 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 37752, SERIAL# (B)(4); PRODUCT TYPE RECHARGER PRODUCT ID 37743, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT REQUESTED A ¿JUMP START¿ OF THEIR IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS FURTHER REPORTED A COMMUNICATION PROBLEM WAS NOTED AND THE POTENTIAL FOR OVERDISCHARGE WAS DISCUSSED WITH THE PATIENT. IT WAS STATED, THE PATIENT HAD FALLEN A FEW MONTHS PRIOR TO REPORT AND THAT THEY ¿DIDN¿T KNOW IF THAT MIGHT HAVE CAUSED SOMETHING TO BREAK LOSE.¿ IT WAS REPORTED THAT PRIOR TO THE FALL, THE PATIENT HAD NOT USED HER INS OR CHARGED IT FOR FOUR TO SIX MONTHS. THE PATIENT WAS REDIRECTED TO HER HEALTHCARE PROVIDER (HCP). THE INS WAS EXPLANTED. AN OVERDISCHARGE WAS CONFIRMED AND THE DEVICE WAS UNABLE TO GET OUT OF IT. IT HAD BEEN IN OVERDISCHARGE FOR OVER A YEAR. NO STIMULATION WAS NOTED AS A PATIENT SYMPTOM. THE LOCATION OF THE ISSUE/SYMPTOM WAS STATED TO BE THE DEVICE POCKET. FOLLOW-UP WAS CONDUCTED TO DETERMINE IF THE PATIENT WAS RECEIVING EFFECTIVE THERAPY AFTER THE REPLACEMENT. THE DEVICE WAS RETURNED BUT HAD NOT YET BEEN ANALYZED AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE INITIATED IF ADDITIONAL INFORMATION IS RECEIVED AND WHEN ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS RECEIVING ADEQUATE COVERAGE AT THEIR POST OPERATION APPOINTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613261 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