BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 3900788 · Received June 27, 2014

    Report

    Report Number
    3004209178-2014-12239
    Event Type
    Injury
    Date Received
    June 27, 2014
    Report Date
    June 4, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 39286-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: NEU _PTM_PROG, SERIAL# UNKNOWN, PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: NEU_RECHARGER_ACC, SERIAL# UNKNOWN, PRODUCT TYPE: RECHARGER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE CONSUMER REPORTED THAT BECAUSE OF WHERE THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS IMPLANTED AND BECAUSE, HE WAS DISABLED AND HAD TO SIT IN A WHEELCHAIR ALL THE TIME, THE INS STARTED TO COME THROUGH THE SKIN AFTER IMPLANT. THE PATIENT HAD TO HAVE THE INS MOVED IN (B)(6) 2015. NOW, THE INS WAS IN HIS STOMACH AND THE DOCTOR HAD TO USE AN EXTENSION AND THE PATIENT COULD FEEL WHERE THE EXTENSION CONNECTED TO THE INS THROUGH THE SKIN. IT WAS NOTED THE PATIENT HAD FULLY RECOVERED, AND THAT THIS WAS A GRADUAL CHANGE IN SYMPTOMS AT THE INS POCKET.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BATTERY WAS UNCOMFORTABLE IN THE LOCATION AND THE PATIENT FELT IT WAS STARTING TO THIN THE SKIN. IT WAS NOTED THAT A REVISION WAS REQUIRED AS A RESULT AND THE BATTERY WAS MOVED IN SURGERY. IT WAS NOTED THAT THERE WAS IMPEDANCE TESTING. IT WAS UNKNOWN IF ANY PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THE EVENT. IT WAS FURTHER REPORTED THAT IMPEDANCES WERE WITHIN NORMAL LIMITS. IT WAS NOTED THAT THE PATIENT HAD NOT BEEN SINCE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377276 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