BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESCAN

    MDR report key: 4950750 · Received July 29, 2015

    Report

    Report Number
    3004209178-2015-14313
    Event Type
    Injury
    Date Received
    July 29, 2015
    Report Date
    July 10, 2015
    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 Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 97740, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT'S BATTERY WAS POKING THROUGH SKIN. THE PATIENT HAD GONE TO THE EMERGENCY ROOM AFTER BEING IN A CAR WRECK AND WAS TOLD HER BATTERY WAS VISIBLE THROUGH SKIN AND NEEDED TO GET CHECKED AS SOON AS POSSIBLE. THE PATIENT HAD RECENTLY LOST A SIGNIFICANT AMOUNT OF WEIGHT AND SHE HAD RECENTLY BEEN IN A CAR ACCIDENT. THERE WAS NO INDICATION OF PAIN, THE SKIN BEING HOT TO THE TOUCH, OR ANY SIGNS OF INFECTION. THE PATIENT'S HEALTHCARE PROVIDER (HCP) THOUGHT THE IMPLANTABLE NEUROSTIMULATOR (INS) ERODING THROUGH SKIN WAS POSSIBLY DUE TO SIGNIFICANT FAT LOSS. THE POCKET WAS IRRIGATED WITH ANTIBIOTICS AND THE INS WAS EXPLANTED AS A PRECAUTION, BUT THE LEADS WERE LEFT IN PLACE. THE POCKET SITE WAS CLOSED WITH NO DIFFICULTY. THE EVENT OCCURRED DURING NORMAL USE. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE WITH NO INJURY. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER REPRESENTATIVE REPORTED THAT WHEN THE BATTERY WAS REMOVED IT WAS NOTICED THAT THE SITE WAS INFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494232 SURESCAN STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 97702

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR Required Intervention