BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 2778427 · Received October 9, 2012

    Report

    Report Number
    3004209178-2012-09045
    Event Type
    Injury
    Date Received
    October 9, 2012
    Report Date
    September 21, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3998, LOT # V233248, IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD. PRODUCT ID 3998, LOT # V233248, IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD. PRODUCT ID 37743, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER. PRODUCT ID 3708340, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE EXTENSION. PRODUCT ID 3708340, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE EXTENSION. ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF DEVICE, MODEL# 37702 SERIAL # (B)(4), FOUND FUNCTIONALLY OKAY, INSIGNIFICANT ANOMALIES. ANALYSIS OF EXTENSION, SERIAL # (B)(4), FOUND EXTENSION BODY CUT THROUGH, PRODUCT SEGMENTED. NO SIGNIFICANT ANOMALY. ANALYSIS OF THE EXTENSION, SERIAL # (B)(4), FOUND EXTENSION BODY CUT THROUGH, PRODUCT SEGMENTED. NO SIGNIFICANT ANOMALY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BATTERY WAS NO LONGER EFFECTIVE AND WAS REPLACED WITH ANOTHER MANUFACTURER'S DEVICE. IT WAS REPORTED THAT THERE WAS NO PATIENT DEATH ASSOCIATED WITH THE EVENT AND THAT THE PATIENT RECOVERED WITHOUT SEQUELA. THE PAPERWORK RETURNED WITH THE DEVICE STATED THAT IT WAS RETURNED TO THE MANUFACTURER FOR DISPOSAL ONLY BUT THAT THE DEVICE COULD BE DISASSEMBLED FOR ANALYSIS. THE RETURNED PAPERWORK ALSO STATED THAT THE DEVICE WAS IMPLANTED ON (B)(6) 2009, WHICH WAS DIFFERENT FROM THE IMPLANT DATE IN THE MANUFACTURER'S DEVICE REGISTRY RECORDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention