BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED

    MDR report key: 2565060 · Received May 8, 2012

    Report

    Report Number
    3004209178-2012-03096
    Event Type
    Injury
    Date Received
    May 8, 2012
    Report Date
    April 12, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID (B)(4), LOT# V645701, IMPLANTED: 2012 (B)(6), EXPLANTED: PRODUCT TYPE LEAD; PRODUCT ID (B)(4), LOT# V638131, IMPLANTED: 2012 (B)(6), EXPLANTED: PRODUCT TYPE LEAD; PRODUCT ID (B)(4), SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID (B)(4), SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID (B)(4), SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), EXPLANTED: PRODUCT TYPE EXTENSION; PRODUCT ID (B)(4), SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), EXPLANTED: PRODUCT TYPE EXTENSION; PRODUCT ID (B)(4), LOT# V820870, IMPLANTED: 2012 (B)(6), EXPLANTED: PRODUCT TYPE LEAD; PRODUCT ID (B)(4), LOT# V765576, IMPLANTED: 2012 (B)(6), EXPLANTED: PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED A POST-OPERATIVE WOUND INFECTION. THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS IMPLANTED IN THE PATIENT'S ABDOMEN, WHICH REQUIRED A SECOND PREP AND DRAPE DURING THE IMPLANT PROCEDURE (FIRST PRONE, THEN LATERAL). IT WAS NOTED THAT A PACKAGE OF MEDICAL ADHESIVE WAS USED DURING SURGERY. THE INS WAS SCHEDULED TO BE EXPLANTED (B)(6) 2012. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A TOTAL SYSTEM EXPLANT DUE TO INFECTION. THE SYMPTOMS OF INFECTION WERE DRAINAGE AND PAIN. THE INFECTION WAS LOCATED AT THE DEVICE POCKET. IT WAS CULTURED AND FOUND TO BE A STAPH INFECTION. IT WAS CONFIRMED THE PATIENT DID NOT HAVE MENINGITIS. THE PATIENT RECEIVED PERIOPERATIVE ANTIBIOTICS, AS WELL AS INTRAVENOUS (IV) AND ORAL ANTIBIOTICS. THE INFECTION WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT PUERTO RICO OPERATIONS CO 37713

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention