BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 3002165 · Received March 13, 2013

    Report

    Report Number
    3004209178-2013-03645
    Event Type
    Injury
    Date Received
    March 13, 2013
    Report Date
    February 20, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3708140, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2013, PRODUCT TYPE EXTENSION; PRODUCT ID 3708140, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2013, PRODUCT TYPE EXTENSION; PRODUCT ID 39286-65, LOT # V483909002, EXPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID NEU_SILICONEANCHOR, EXPLANTED: (B)(6) 2013, PRODUCT TYPE ACCESSORY; PRODUCT ID NEU_SILICONEANCHOR, EXPLANTED: (B)(6) 2013, PRODUCT TYPE ACCESSORY; PRODUCT ID 37744, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3708140, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2013, PRODUCT TYPE EXTENSION; PRODUCT ID 3708140, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2013, PRODUCT TYPE EXTENSION. ANALYSIS OF THE INS RESULTED IN NO ANOMALIES FOUND. ANALYSIS OF THE EXTENSIONS RESULTED IN THE DISTAL END OF SET SCREW NOT TIGHT TO LEAD, CAUSING THE LEAD PROXIMAL END TO MIGRATE OUT OF THE EXTENSION. SCRAPE MARKS WERE OBSERVED ON THE #0 AND #8 CONNECTOR SLEEVES ON THE LEAD. ANALYSIS OF THE LEAD RESULTED IN THE LEAD BODY CUT THROUGH, THE PRODUCT WAS SEGMENTED. ANALYSIS OF THE ANCHORS RESULTED IN NO ANOMALIES FOUND.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID NEU_SILICONEANCHOR, PRODUCT TYPE ACCESSORY; PRODUCT ID NEU_SILICONEANCHOR, PRODUCT TYPE ACCESSORY; PRODUCT ID 39286-65, LOT # V483909002, PRODUCT TYPE LEAD; PRODUCT ID 37744, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER; PATIENT PRODUCT ID (B)(4), SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2013, PRODUCT TYPE EXTENSION; PRODUCT ID 3708140, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2013, PRODUCT TYPE EXTENSION. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT'S DEVICE WAS EXPLANTED DUE TO LOSS OF EFFICACY, MYELOPATHY AND MYELOPATHIC SIGNS. IT WAS ALSO REPORTED THERE WAS NO INJURY TO THE PATIENT AND THE PATIENT RECOVERED WITHOUT SEQUELA. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106004 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