BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESCAN

    MDR report key: 3944750 · Received July 18, 2014

    Report

    Report Number
    3004209178-2014-13251
    Event Type
    Injury
    Date Received
    July 18, 2014
    Date of Event
    August 15, 2013
    Report Date
    June 24, 2014
    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

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 97754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER; PRODUCT ID 97740, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD; PRODUCT ID 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) MAY BE FLIPPED. IT WAS NOTED THAT THE PATIENT HAD DIFFICULTY RECHARGING SINCE INITIAL IMPLANT. IT WAS NOTED THAT THE ANTENNA LOCATOR INDICATED THAT THE INS WAS NOT FLIPPED. IT WAS NOTED THAT THE MANUFACTURING REPRESENTATIVE COULD CONNECT WITH THE PATIENT¿S RECHARGER, THOUGHT VIABLE COUPLING WAS NOT ACHIEVED. IT WAS NOTED THAT THE PHYSICIAN LOOKED AT THE INS UNDER FLUOROSCOPY AND CONCLUDED THAT THE INS WAS NOT FLIPPED. IT WAS NOTED THAT ¿DUE TO THE PATIENT¿S SIGNIFICANT BODY MASS INDEX (BMI) AND THE LOCATION OF THE INS, IT WAS DECIDED TO REVISE THE LOCATION OF THE INS.¿ THE DATE OF THE PROCEDURE WAS UNKNOWN AT THE TIME OF THE REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD AN IMPLANTABLE NEUROSTIMULATOR (INS) REVISION ON (B)(6)-2014. THE INS WAS MOVED JUST A BIT. NO ADDITIONAL PRODUCT WAS USED AND SUCCESSFUL CHARGING WAS CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422845 SURESCAN STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 00029 YR Required Intervention