BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 2935788 · Received January 30, 2013

    Report

    Report Number
    3004209178-2013-01133
    Event Type
    Injury
    Date Received
    January 30, 2013
    Report Date
    January 9, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2012. PRODUCT TYPE: LEAD: PRODUCT ID 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2012. PRODUCT TYPE: LEAD: PRODUCT ID 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2012. PRODUCT TYPE: LEAD: PRODUCT ID 37744, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD A FULL SYSTEM EXPLANT "ABOUT A YEAR AGO" DUE TO A REACTION AT THE DEVICE POCKET AT WHICH TIME THE POCKET WOUND DEHISCED. THE REPORTER STATED THAT IT WAS NOT FULLY ESTABLISHED IF THE PATIENT HAD AN ALLERGIC REACTION TO THE SYSTEM OR HAD AN INFECTION. IT WAS REPORTED THAT THE PATIENT WAS POSITIVE FOR INFECTION AT THE TIME OF THE EXPLANT, BUT THE PATIENT'S DOCTOR THOUGHT THAT IT MAY HAVE BEEN DUE TO THE POCKET DEHISCING. 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 AN IMPLANTABLE NEUROSTIMULATOR (INS) WAS REMOVED DUE TO INFECTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. WHEN RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40391 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT PUERTO RICO OPERATIONS CO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention