BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 3202636 · Received July 2, 2013

    Report

    Report Number
    3004209178-2013-11201
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    April 8, 2013
    Report Date
    June 25, 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

    PRODUCT ID: 3777-60 LOT# SERIAL# (B)(4), IMPLANTED: 2013 (B)(6), PRODUCT TYPE LEAD PRODUCT ID: 3777-60 LOT# SERIAL# (B)(4), IMPLANTED: 2013 (B)(6), PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE RELATIONSHIP BETWEEN THE DEVICE AND ABDOMINAL PAIN WAS UNDETERMINED. THE PATIENT STILL HAD THE PAIN AFTER EXPLANT.

    Description of Event or Problem · 1

    IT WAS ORIGINALLY REPORTED IN MANUFACTURER¿S REPORT # 3004209178-2013-02849 THAT THE PATIENT EXPERIENCED SURGICAL COMPLICATIONS FOLLOWING IMPLANTABLE NEUROSTIMULATOR (INS) REVISION ON 2013 (B)(6). THE PATIENT HAD ABDOMINAL PAIN, FOR WHICH THE CAUSE WAS UNKNOWN. THE INS HAD NOT BEEN TURNED ON. IT WAS LATER REPORTED THAT THE PATIENT HAD THE INS EXPLANTED ON 2013 (B)(6). ADDITIONAL INFORMATION INDICATED THE PATIENT ACTUALLY UNDERWENT A DEVICE REPLACEMENT ON 2013 (B)(6). THE INFORMATION REGARDING THE PATIENT¿S ABDOMINAL PAIN AND SUBSEQUENT EXPLANT PERTAINS TO THIS MANUFACTURER¿S REPORT AND ANY ADDITIONAL INFORMATION REGARDING THIS EVENT WILL BE REPORTED IN THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302190 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