BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 4250569 · Received November 14, 2014

    Report

    Report Number
    3004209178-2014-21578
    Event Type
    Injury
    Date Received
    November 14, 2014
    Report Date
    November 10, 2014
    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
    UT, 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: 37746, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. 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 HAD A REVISION PERFORMED IN (B)(6) 2014. THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) WAS INITIALLY IMPLANTED IN THE WRONG PLACE IN THE PATIENT¿S BUTTOCK AND IT POKED THE PATIENT. THE PATIENT NOTED THAT THEY HAD A ¿SPINAL CORD LEAK¿ AND HAD TO HAVE IT REPAIRED. WHEN THEY HAD IT REPAIRED IT KNOCKED THEIR ELECTRODES OUT OF PLACE AND THE PATIENT WAS ONLY GETTING ONE PROGRAM FROM (B)(6) 2014. THE PATIENT WAS LEFT IN THE HOSPITAL FOR 4 DAYS WITH A SPINAL HEADACHE. THE PATIENT¿S SYSTEM WAS WORKING OPTIMALLY AFTER THE REVISION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS ONLY GETTING ONE PROGRAM FROM (B)(6) 2013 TO (B)(6) 2014.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD INADEQUATE STIMULATION AFTER THE FIRST PLACEMENT. IT WAS NOT DEVICE RELATED, BUT A PLACEMENT ISSUE. SUBOPTIMAL INITIAL PLACEMENT REQUIRED REVISION TO IMPROVE THE STIMULATION PATTERN. THE PATIENT RECOVERED WITHOUT PERMANENT IMPAIRMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737384 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 Hospitalization| R