BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESCAN

    MDR report key: 4090522 · Received September 15, 2014

    Report

    Report Number
    3004209178-2014-17056
    Event Type
    Injury
    Date Received
    September 15, 2014
    Date of Event
    August 20, 2014
    Report Date
    August 21, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 39565-30, SERIAL# (B)(4) IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 39565-30, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, EXPLANTED: (B)(6) 2014, PRODUCT TYPE; EXTENSION. PRODUCT ID: 97740, SERIAL# (B)(4), PRODUCT TYPE; PROGRAMMER, PATIENT. PRODUCT ID: 97754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BOTH SURGICAL SITES OF THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) WERE INFECTED WITH (B)(6) SO THE SURGEON EXPLANTED THE INS SYSTEM. IT WAS NOTED THAT THE PATIENT ¿LOVED¿ THE INS DEVICE THERAPY PRIOR TO ITS REMOVAL. THE DATE OF ONSET OF THE INFECTION WAS NOTED AS (B)(6) 2014. THE PHYSICIAN ELECTED TO IMPLANT A NEW LEAD COMPONENT IN THE EPIDURAL SPACE (AFTER VIGOROUS CLEANING) TO ¿HOLD¿ THE SPACE FOR A FUTURE IMPLANT. NO INTERROGATIONS WERE NEEDED OR PERFORMED ON THE DEVICE. FOLLOW UP INFORMATION REPORTED THAT PERIOPERATIVE ANTIBIOTICS WERE ADMINISTERED AND THE PATIENT DID NOT HAVE (B)(6). REPORTED PATIENT SYMPTOMS DURING THE INFECTION EVENT WERE FEVER, REDNESS, SWELLING, DRAINAGE, PAIN, AND INCISIONAL WOUND OPENING. THE PRIMARY LOCATION OF THE INFECTION WAS REPORTED AT THE DEVICE POCKET AND LUMBAR REGION. A CULTURE WAS TAKEN AT THE SAME SITES GREW (B)(6) ORGANISM. INTRAVENOUS ANTIBIOTIC TREATMENT WAS INSTITUTED FOR THE INFECTION AND THE PATIENT OUTCOME WAS REPORTED AS ¿ONGOING¿. IT WAS NOTED THAT THE PATIENT DID HAVE A HISTORY OF (B)(6)INFECTIONS. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569836 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention