BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 2935524 · Received January 30, 2013

    Report

    Report Number
    3004209178-2013-01122
    Event Type
    Injury
    Date Received
    January 30, 2013
    Report Date
    January 9, 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
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 3777-45 LOT# SERIAL# (B)(4), IMPLANTED: 2007 (B)(6), EXPLANTED: 2010 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 37754 LOT# SERIAL# (B)(4), PRODUCT TYPE RECHARGER PRODUCT ID, 37744 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON OR ABOUT (B)(6) 2012, A PATIENT EXPERIENCED SHOCKING AND BURNING FROM HER IMPLANTABLE NEUROSTIMULATOR (INS) SYSTEM. SHE SHUT THE SYSTEM OFF AND IT WAS VERIFIED WITH THE COMPANY REPRESENTATIVE THAT THE INS WAS OFF. THE PATIENT HAD A HISTORY OF FALLING ALTHOUGH THERE WAS NO FALL IMMEDIATELY PRIOR TO THIS ISSUE. THE PATIENT WOULD LIKE THE SYSTEM TAKEN OUT. IT WAS STATED THAT THE REMOVAL WOULD BE PURSUED IN A COUPLE OF MONTHS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. WHEN RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT¿S SYSTEM WAS REMOVED BECAUSE IT WAS IMPLANTED ¿UPSIDE DOWN AND LEADS CONNECTOR TO WRONG PORTION OF SPINE.¿ THE PATIENT STATED THAT THERAPY WAS SUPPOSED TO HELP HER PAIN IN THE RIGHT ANKLE BUT ¿ALL IT COULD WAS STOMACH.¿ THE PATIENT STATED THAT THE LEAD WAS ATTACHED IN THE WRONG LOCATION. THE PATIENT WAS UNABLE TO RECHARGE PROPERLY BECAUSE IT WAS IMPLANTED WRONG. THE PATIENT STATED THAT THE DEVICE DID NOT PROVIDE THERAPY AT ALL. THE HEALTH CARE PROVIDER (HCP) THAT REMOVED THE DEVICE TOLD THE PATIENT THAT IT WAS UPSIDE DOWN. THE PATIENT NOTED ¿IT WAS A HORRIBLE EXPERIENCE FOR HER AND THE ENTIRE TIME THE THERAPY DID NOT WORK.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41442 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 00061 YR Required Intervention