BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 2802874 · Received October 24, 2012

    Report

    Report Number
    3004209178-2012-09477
    Event Type
    Injury
    Date Received
    October 24, 2012
    Report Date
    September 26, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 39565-65 LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD; PRODUCT ID, 39565-30 LOT# SERIAL# (B)(4), 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

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT'S DEVICE WAS IMPLANTED AT THE TOP OF HER RIGHT BUTTOCK. IT WAS NOTED THAT THE PATIENT STRUGGLED WITH GETTING THE DEVICE TO CHARGE, BUT RECEIVED HELP. IT WAS ALSO STATED THAT THE PATIENT'S BATTERY WAS "NOT IN THE POCKET RIGHT". IT WAS STATED THAT THE PATIENT WAS GOING TO HAVE THEIR THIRD SURGERY TO "CORRECT IT".

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT WAS RECEIVING NO STIMULATION AND THAT HE DEVICE WAS NOT WORKING. IT WAS DISCOVERED THAT THE DEVICE WAS OFF. THE PATIENT WAS ASSISTED IN TURNING THE DEVICE ON AND TO A COMFORTABLE LEVEL. ADDITIONAL INFORMATION RECEIVED APPROXIMATELY TWO WEEKS LATER REPORTED THAT THE PATIENT HAD COUPLING AND COMMUNICATION ISSUES. THE DEVICE MOVED "A LOT" IN THE POCKET AND IT WAS "VERY LOOSE." IT WAS NOTED THAT THE "DEVICE COULD FLIP AND PROTRUDE SIDEWAYS OCCASIONALLY." THE PATIENT HAD EXPERIENCED PAIN DUE TO THE DEVICE BEING LOOSE. THE PATIENT WAS ABLE TO OBTAIN FULL COUPLING BARS. ONE WEEK LATER THE PATIENT WAS STILL HAVING ISSUES REGARDING THE LOOSE POCKET AND WAS ATTEMPTING TO SEEK MEDICAL ASSISTANCE. PATIENT OUTCOME WAS NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD A "SECOND" SURGERY ON (B)(6) 2012 TO REPOSITION THE DEVICE BECAUSE IT "DID NOT ANCHOR IN." THE PATIENT STATED THE HEALTH CARE PROVIDERS (HCP) WERE ORIGINALLY GOING TO PUT ANOTHER STITCH IN TO ANCHOR THE DEVICE, BUT WHEN THEY "WENT IN" THEY DECIDED TO REMOVE IT AND REPOSITION IT "ALTOGETHER."

    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