BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESCAN

    MDR report key: 3875708 · Received June 16, 2014

    Report

    Report Number
    3004209178-2014-11658
    Event Type
    Injury
    Date Received
    June 16, 2014
    Report Date
    May 27, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 977A260, SERIAL# (B)(4), EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID 977A260, SERIAL# (B)(4), EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. (B)(4). PRODUCT CODE: CHANGED FROM GZB TO LGW.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 97754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 97740, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT WENT TO ANSWER THE DOOR AND HER NEIGHBOR KNOCKED HER OVER AND THE IMPLANT IN HER BACK MOVED. THIS HAPPENED 3-4 DAYS AGO. THERE WAS A HOLE IN THE PATIENT¿S BACK JUST ABOVE THE IMPLANT, IT WAS BULGING AND DISCOLORED. THE PATIENT DOES NOT SEE HER HEALTH CARE PROVIDER (HCP) TILL THE (B)(6). THE PATIENT ASKED ABOUT GOING TO THE HOSPITAL TO GET CHECKED OUT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) SYSTEM WAS EXPLANTED DUE TO INFECTION. THERE WAS NO ALLEGED PRODUCT ISSUES REPORTED AND NO DIAGNOSTICS OR TROUBLESHOOTING WERE PERFORMED. THE EXPLANTED PRODUCTS WERE NOT RETURNED TO THE MANUFACTURER FOR ANALYSIS AND WERE DISCARDED BY THE CUSTOMER. IT WAS ALSO NOTED THAT THE CAUSE OF THE ISSUE WAS UNKNOWN AND THAT THERE WERE NOT REPORTED COMPLICATIONS OR SYMPTOMS ASSOCIATED WITH THE EVENT. THE PATIENT STATUS AT THE TIME OF THE REPORT WAS NOTED AS 'ALIVE - NO INJURY'. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351986 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 00047 YR Required Intervention