BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 5103646 · Received September 25, 2015

    Report

    Report Number
    3007566237-2015-02729
    Event Type
    Malfunction
    Date Received
    September 25, 2015
    Date of Event
    August 28, 2015
    Report Date
    March 22, 2016
    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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON DEVICE RETURN, ANALYSIS FOUND A DAMAGED CABLE ASSEMBLY. THE REPAIR DEPARTMENT REPLACED THE CABLE ASSEMBLY WITH METAL CONNECTOR AT THE END OF THE CABLE BROKEN OFF.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID: 37761, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 37761, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. (B)(4).

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CONCLUSION CODE UPDATED.

    Additional Manufacturer Narrative · 1

    SUPPLEMENTAL TO UPDATE CONCLUSION CODE NO LONGER APPLIES, RESULT CODE NO LONGER APPLIES, NEW CODES ARE FOR DESKTOP CHARGER SERIAL NUMBER (B)(4). CHANGE TO REPORT SOURCE, NO COMPANY REPRESENTATIVE REPORTED INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    THE CONSUMER REPORTED THERE WAS A BROKEN/BENT/LOOSE CONNECTOR ON THE DESKTOP CHARGER (DTC). THE SILVER CONNECTOR BROKE. THE PATIENT REPORTED PAIN. THE PATIENT WAS REDIRECTED TO THE REPAIR DEPARTMENT. THE AC ADAPTOR HAD THE CONNECTOR BROKEN OFF. MEDICAL HISTORY INCLUDES SPINAL PAIN AND POST LUMBAR LAMINECTOMY SYNDROME. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS CLARIFIED THAT THE SILVER CONNECTOR ON THE CORD CAME APART AND THE DESKTOP CHARGER WAS BROKEN AND NOT WORKING. THE PATIENT'S BACK WAS NOT DOING WELL AND THEY COULD HARDLY MOVE. THE PATIENT STATED THEY HAVE NO STIMULATION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE CONSUMER REPORTED THE NEW DESKTOP CHARGER RESOLVED THE LOSS OF STIMULATION AND BACK ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636289 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 00043 YR