BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 3241137 · Received July 22, 2013

    Report

    Report Number
    3004209178-2013-12102
    Event Type
    Injury
    Date Received
    July 22, 2013
    Report Date
    June 27, 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
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 37746, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 37754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVERE PAIN AT THE POCKET SITE THAT RADIATED TO THE PATIENT¿S RIGHT HIP. IT WAS STATED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) TURNED ON AND OFF BY ITSELF AND CAUSED ¿VERY HIGH SHOCKS.¿ THE PATIENT¿S DOCTOR WAS REPORTEDLY GOING TO EXPLANT. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT EXPERIENCED ACUTE PAIN. THE PATIENT HAD A REVISION ON (B)(6) 2013, DUE TO THE SHARP PAIN AT THE POCKET SITE THAT THE PATIENT HAD SINCE ONE MONTH AFTER IMPLANT. IT WAS STATED THAT THE DEVICE POCKET WAS VERY SENSITIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340367 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 00038 YR Required Intervention