BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE

    MDR report key: 2891764 · Received December 31, 2012

    Report

    Report Number
    3004209178-2012-12415
    Event Type
    Injury
    Date Received
    December 31, 2012
    Report Date
    December 10, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3998, LOT# V175498, SERIAL# IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 37083-40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2013, PRODUCT TYPE EXTENSION; PRODUCT ID 3708340, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2013, PRODUCT TYPE EXTENSION; PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: (B)(6)2006, PRODUCT TYPE RECHARGER; PRODUCT ID 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3998, LOT# V175498, IMPLANTED: (B)(6) 2009. PRODUCT TYPE: LEAD: PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006. PRODUCT TYPE: RECHARGER: PRODUCT ID 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006. PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 3708340, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009. PRODUCT TYPE: EXTENSION: PRODUCT ID 37083-40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009. PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE AREA AROUND THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) WAS "BLACK AND BLUE" AND THE PATIENT COULD SEE THE CORNER OF THE INS. THE PATIENT WAS NOTED TO HAVE REQUESTED FOR INFORMATION ON HOW TO MANAGE THE INS ERODING THROUGH HIS SKIN AND HAD NOT RECEIVED ANY DIRECTIONS ABOUT WOUND CARE PREVIOUSLY. THE REPORTER INDICATED THAT THE PATIENT DID NOT HAVE A FEVER, REDNESS OR OTHER SIGNS OF AN INFECTION. THE PATIENT WAS ALSO REPORTED TO HAVE PAIN ALONG HIS SIDE FROM HIS NECK DOWN TO THE INS. THE PATIENT'S BACK WAS ALSO NOTED TO FEEL "PRESSURIZED" BUT THE PATIENT WAS UNSURE THAT FEELING HAD ANYTHING TO DO WITH THE EROSION. THE PATIENT WAS SCHEDULED TO SEE HIS HEALTHCARE PROVIDER (HCP) FOR THIS ISSUE THE FOLLOWING DAY. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE INS (IMPLANTABLE NEUROSTIMULATOR) WAS "POPPING" OUT OF THE SKIN SO IT WAS MOVED TO THE OTHER SIDE AND IT DID THE SAME THING SO THEN IT WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention