BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE PRIME

    MDR report key: 2640474 · Received July 5, 2012

    Report

    Report Number
    3004209178-2012-05233
    Event Type
    Injury
    Date Received
    July 5, 2012
    Report Date
    June 7, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37744, SERIAL# (B)(4), PRODUCT TYP PROGRAMMER, PATIENT PRODUCT ID 3708220, LOT# SERIAL# (B)(4), IMPLANTED: 2012-(B)(6), EXPLANTED: 2012-(B)(6), PRODUCT TYP EXTENSION PRODUCT ID 3487A-45, LOT# V884731, PRODUCT TYP LEAD PRODUCT ID 3487A-45, LOT# V896858, PRODUCT TYP LEAD F.FOR USE BY USER FACILITY/IMPORTER(DEVICES ONLY). (B)(4).

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION RECEIVED FROM THE HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT THE DATE ONSET OF THE INFECTION WAS (B)(6) 2012 AND PATIENT SYMPTOMS OF REDNESS, SWELLING, DRAINAGE, INCISIONAL WOUND OPENING, AND POCKET EROSION WERE NOTED. THE PRIMARY SITE OF THE INFECTION WAS THE INS POCKET SITE. NO CULTURES WERE REPORTED TO HAVE BEEN TAKEN. THE PATIENT TREATMENTS INCLUDED BOTH ORAL AND IV ANTIBIOTICS WITH EXPLANT OF TOTAL IMPLANTABLE NEUROSTIMULATOR (INS) SYSTEM. THE PATIENT OUTCOME WAS REPORTED AS INFECTION RESOLVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT'S ENTIRE SYSTEM WAS REMOVED DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE PRIME STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT PUERTO RICO OPERATIONS CO 37701

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention