BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 2834252 · Received November 15, 2012

    Report

    Report Number
    3004209178-2012-10333
    Event Type
    Injury
    Date Received
    November 15, 2012
    Report Date
    October 17, 2012
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR FOUND NO ANOMALY. ANALYSIS OF THE EXTENSION FOUND THAT THE BODY WAS CUT THROUGH AND THE PRODUCT WAS SEGMENTED. ANALYSIS OF THE LEAD (S/N: (B)(4)) FOUND THAT THE BODY WAS CUT THROUGH AND THE PRODUCT WAS SEGMENTED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3888-33, LOT# VA02DN8, IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD, PRODUCT ID 3888-33, LOT# VA02DN8, IMPLANTED: 2012 (B)(6,) PRODUCT TYPE LEAD, PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD, PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER, PRODUCT ID 37746, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3708220, SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE EXTENSION. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE WEEK POST-OP A LEAD HAD MIGRATED AND REVISION WAS NECESSARY. THE STIMULATION WAS REPORTED IN THE "WRONG PLACE."{ THE PATIENT HAD "GOOD" STIMULATION IN THE "RIGHT CHEST AREA" POST-OP, BUT AT THE ONE WEEK FOLLOW UP THE STIMULATION WAS IN THE "ABDOMEN AND RIGHT HIP." ON (B)(6) 2012 IT WAS REPORTED THAT THE POCKET HAD BEEN OPENED AND AN INFECTION WAS FOUND. THE ENTIRE SYSTEM WAS THUS EXPLANTED. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2012 REPORTED THAT THE PATIENT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 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