BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 4210852 · Received October 29, 2014

    Report

    Report Number
    3004209178-2014-20614
    Event Type
    Injury
    Date Received
    October 29, 2014
    Report Date
    October 8, 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
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37754, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37746, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3708220, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE EXTENSION; PRODUCT ID 3708220, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE EXTENSION; PRODUCT ID 3487A-56, LOT # V450602, IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 3487A-56, LOT # VA01WBL, IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 3888-33, LOT # V378301, IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 3888-56, LOT # V670561, IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A CONFIRMED OVERDISCHARGE, AND IT WAS THE PATIENT¿S FIRST OVERDISCHARGE. A PHYSICIAN MODE RECHARGE (PMR) WAS PERFORMED. THE PATIENT WAS NOT ABLE TO STAY TO COMPLETE RECHARGING AND CLEAR THE POWER ON RESET (POR). THE PATIENT INFORMED THE MANUFACTURER REPRESENTATIVE THAT THE SURGEON WAS PLANNING TO REVISE THE IMPLANTABLE NEUROSTIMULATOR (INS) POCKET FOR BETTER COUPLING, WHICH, THE PATIENT NOTED THAT WAS THE REASON SHE LET THE IMPLANTABLE NEUROSTIMULATOR (INS) OVERDISCHARGE, POOR COUPLING. THE POCKET REVISION WAS PLANNED FOR (B)(6) 2014. PATIENT STATUS AT THE TIME OF THE REPORT WAS ALIVE, NO INJURY. THE PATIENT SYMPTOM OR COMPLICATION ASSOCIATED WITH THE EVENT WAS LESS THAN 50% THERAPY RELIEF AT THE DEVICE POCKET. IT WAS LATER REPORTED THAT THE POR WAS CLEARED BEFORE SURGERY (0X8). THE PATIENT WAS ENCOURAGED TO CONTINUE RECHARGING. ORIGINAL POCKET WAS VERY LOW IN THE BUTTOCK BUT THE SURGEON MOVED IT UP APPROXIMATELY 4 INCHES. THERE WAS GOOD COUPLING ACHIEVED POST-OPERATIVE, AND THE PATIENT WOULD FOLLOW-UP IN TWO WEEKS AFTER THE TIME OF THE REPORT. INFORMATION REGARDING PATIENT OUTCOME AFTER THE REVISION HAS BEEN REQUESTED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS BROUGHT OUT OF OVERDISCHARGE. THE PATIENT WAS DOING WELL AND RECEIVING EFFECTIVE THERAPY AFTER THE REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693423 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention