BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3120357 · Received May 20, 2013

    Report

    Report Number
    3004209178-2013-07896
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Report Date
    May 2, 2013
    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

    PRODUCT ID 3708220 LOT# SERIAL# (B)(4), IMPLANTED: 2007 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID 389233 LOT# J0327034V, PRODUCT TYPE LEAD PRODUCT ID 389233 LOT# J0327034V, IMPLANTED: 2003 (B)(6), PRODUCT TYPE LEAD PRODUCT ID 389233 LOT# J0327034V, IMPLANTED: 2003 (B)(6), PRODUCT TYPE LEAD PRODUCT ID 37754 LOT# SERIAL# (B)(4), PRODUCT TYPE RECHARGER PRODUCT ID 37746 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD EXPERIENCED SHOCKING/JOLTING SENSATION. THE PATIENT CONTINUED HAVING SHOCKING/JOLTING SENSATION VERY FREQUENTLY EVEN WHEN IN A 'STILL' POSITION AFTER THE CHANGE OUT OF IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS STATED THAT THE PATIENT CONTINUED TO HAVE THE SAME RESPONSE "IF NOT WORSE." IT WAS ATTEMPTED TO ACTIVATE SENSOR BUT PATIENT'S RESPONSE WAS UNSATISFACTORY. AN ELECTRODE IMPEDANCE TEST WAS PERFORMED AND THE ONLY COMBINATION THAT SHOWED <(> <<)> 50 OHMS WERE ELECTRODES 3 <(>&<)> 4. REPROGRAMMING WAS PERFORMED AROUND THOSE ELECTRODES AND PATIENT CONTINUED TO HAVE A FREQUENT UNCOMFORTABLE JOLTING/SHOCKING SENSATION. PATIENT STATUS AT TIME OF THIS REPORT WAS NOTED AS ALIVE WITH NO INJURY/NO ADVERSE EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. WHEN RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222358 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