BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 3261651 · Received August 2, 2013

    Report

    Report Number
    3004209178-2013-12675
    Event Type
    Injury
    Date Received
    August 2, 2013
    Report Date
    July 9, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37754, SERIAL# (B)(4). PRODUCT TYPE: RECHARGER: PRODUCT ID 37746, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2013. PRODUCT TYPE: LEAD: PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2013. PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD FLUID COLLECTION AROUND THE IMPLANTABLE NEUROSTIMULATOR (INS) AND THE SYSTEM WAS EXPLANTED. IT WAS NOTED IT WAS UNKNOWN WHEN THE FLUID WAS FOUND AROUND THE INS. IT WAS FURTHER NOTED THE PATIENT¿S HEALTHCARE PROFESSIONAL ASPIRATED THE FLUID AND SENT THE FLUID FOR CULTURE. IT WAS REPORTED THAT THE SYSTEM EXPLANT WAS DUE TO INFECTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THE INFECTION WAS NEAR THE ANCHOR SITE. IT WAS NOTED THE EXPLANT WAS NOT DEVICE RELATED. IT WAS REPORTED THE PATIENT WILL HAVE A DEVICE RE-IMPLANTED ONCE THE INFECTION IS CLEARED UP. IT WAS NOTED THE PATIENT WAS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362960 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 00052 YR Required Intervention