BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 2749036 · Received September 18, 2012

    Report

    Report Number
    9614453-2012-00142
    Event Type
    Injury
    Date Received
    September 18, 2012
    Date of Event
    August 1, 2012
    Report Date
    August 20, 2012
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3999-30, LOT# 0205846950, IMPLANTED: 2012-(B)(6), PRODUCT TYPE LEAD PRODUCT ID 37083-60, SERIAL# (B)(4), IMPLANTED: 2012-(B)(6), PRODUCT TYPE EXTENSION PRODUCT ID 37083-60, SERIAL# (B)(4), IMPLANTED: 2012-(B)(6), PRODUCT TYPE EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER IMPLANT IMPEDANCE VALUES WERE OVER 10,000 OHMS ON ELECTRODES 4-7 AND THE PATIENT HAD NO PARESTHESIA ON THE LEFT SIDE AT SETTINGS AS HIGH AS 9V. IT WAS NOTED THAT DURING THE TRIAL THE PATIENT HAD LEFT SIDE PARESTHESIA AROUND 1V. X-RAYS SHOWED NO PROBLEMS AND PROGRAMMING CHANGES DID NOT HELP. IT WAS NOTED THAT ELECTRODES 4-7 WERE NEVER TESTED DURING THE IMPLANT, THOUGH THE LEAD HAD BEEN IMPLANTED TO THE CERVICAL LEVEL AND THE PATIENT HAD PARESTHESIA TO LEFT SIDE AFTER IMPLANTING. IT WAS REPORTED THAT EXPLANT OF THE LEAD AND / OR EXTENSIONS WAS PLANNED, BUT NO DATE WAS SET. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION REPORTED THAT THE HEALTHCARE PROFESSIONAL BELIEVED THE ISSUE WAS DUE TO A MISTAKE THEY HAD MADE WITH THE LEAD CONFIGURATION PROGRAMMING ("2 PCS OF 4 POLE LEADS"). IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW IPG MFG SWITZERLAND 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention