BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED

    MDR report key: 3940660 · Received July 17, 2014

    Report

    Report Number
    3004209178-2014-13142
    Event Type
    Injury
    Date Received
    July 17, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 1, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 3708160, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708160, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT PRESENT AT THE DOCTOR¿S OFFICE ON (B)(6) 2014 WITH SIGNS AND SYMPTOMS OF AN INFECTION (UNKNOWN TYPE) AT THE POCKET SITE OF THEIR IMPLANTABLE NEUROSTIMULATOR (INS). SYMPTOMS INCLUDED REDNESS, TENDERNESS, AND SWELLING AT THE INS SITE AT THE RIGHT ABDOMEN ALONG WITH A FEVER. IN ADDITION IT WAS NOTED THAT THE PATIENT HAD A LOSS OF REFLEXES IN THE LOWER EXTREMITIES. IT WAS REPORTED THAT THE PATIENT WAS PLACED ON CLINDAMYCIN BUT NO CULTURE WAS TAKEN. NO OTHER DIAGNOSTICS OR TROUBLESHOOTING WAS PERFORMED. THE PATIENT STATUS AT THE TIME OF REPORT WAS NOTED AS ¿ALIVE ¿ NO INJURY¿. FOLLOW UP INFORMATION RECEIVED ON (B)(6) 2014 REPORTED THAT THE PATIENT¿S INS SYSTEM WAS EXPLANTED ON (B)(6) 2014. IT WAS REPORTED THAT CULTURES GREW STAPHYLOCOCCUS EPIDERMIS. IT WAS NOTED THAT THE PATIENT WAS NOW AN IN-PATIENT AND WAS RECEIVING IV VANCOMYCIN (2250 MG EVERY 12 HRS). THE PLAN WAS FOR THE PATIENT TO GO HOME (B)(6) 2014. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT¿S INFECTION RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418465 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37713

    Patients

    Seq Age Sex Outcome Treatment
    1 00048 YR Hospitalization| R