BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2962425 · Received February 14, 2013

    Report

    Report Number
    3004209178-2013-02679
    Event Type
    Injury
    Date Received
    February 14, 2013
    Report Date
    January 29, 2013
    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
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 39565-65 LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 37754 LOT# SERIAL# (B)(4), PRODUCT TYPE RECHARGER PRODUCT ID, 37744 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION FROM THE HEALTHCARE PROVIDER STATED THE PATIENT HAD A REVISION SURGERY ON (B)(6) 2013 DUE TO POOR PLACEMENT OF THE IMPLANTABLE NEUROSTIMULATOR (INS) AND POOR COMMUNICATION WITH THE PATIENT'S CHARGER. IT WAS REPORTED THE PATIENT HAD A CHARGING ISSUE BECAUSE THE INS WAS PROBABLY PLACED TOO DEEP. DURING THE REVISION, THE INS WAS PLACED IN A MORE SUPERFICIAL LOCATION AND IT WAS REPORTED THE DEVICE 'WORKED WELL' AND HAD BETTER FUNCTION. IT WAS REPORTED THE PATIENT DID NOT REQUIRE HOSPITALIZATION AND RECOVERED WITHOUT SEQUELAE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN IMPLANTABLE NEUROSTIMULATOR (INS) MALFUNCTIONED. THE REPORTER STATED THAT THE INS WOULD NOT CHARGE AND THERE WAS NO SIGNAL SO THE DEVICE LOST POWER. IT WAS FURTHER REPORTED THAT A REVISION WAS DONE TO MOVE THE INS. THE INS WAS PUT IN A SECOND TIME ON (B)(6) 2012. THE REPORTER STATED THAT THE DEVICE STILL DID NOT CHARGE "LIKE IT SHOULD," IT TOOK "FOREVER" AND THE PATIENT HAD TO SIT FOR THREE HOURS AT A TIME TO CHARGE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65852 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