BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESCAN

    MDR report key: 5010335 · Received August 18, 2015

    Report

    Report Number
    3004209178-2015-16179
    Event Type
    Injury
    Date Received
    August 18, 2015
    Date of Event
    May 6, 2015
    Report Date
    July 24, 2015
    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
    TN, 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)2015, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT SHE NEVER HAD THERAPEUTIC EFFECT AND EXPERIENCED NAUSEA. THE IMPLANTABLE NEUROSTIMULATOR (INS) STIMULATES THE STOMACH AND CAUSES NAUSEA. THIS OCCURS DAILY. THERE WAS NO TRAUMA OR FALLS THAT COULD BE RELATED TO THIS EVENT. THERE WERE NO STIMULATION ISSUE RELATED TO POSITIONAL MOVEMENT. THERE PATIENT HAS NOT HAD ANY MEDICAL TEST OR EMI ENVIRONMENTAL EXPOSURE. THE DEVICE WAS GOING TO BE REMOVED ON (B)(6) 2015. THE STIMULATION HAS BEEN TURNED OFF SINCE (B)(6) 2015. THE STIMULATION WAS TURNED OFF BECAUSE IT WAS NOT HELPING AND WAS CAUSING NAUSEA. THE INDICATION FOR USE INCLUDED SPINAL PAIN AND FAILED BACK SURGERY SYNDROME. ADDITIONAL INFORMATION HAS BEEN REQUESTED TO FIND OUT THE OUTCOME OF THIS EVENT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    544241 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Required Intervention