BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 2357453 · Received December 5, 2011

    Report

    Report Number
    3004209178-2011-09579
    Event Type
    Injury
    Date Received
    December 5, 2011
    Date of Event
    October 9, 2011
    Report Date
    January 17, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF IMPLANTABLE NEUROSTIMULATOR (INS) MODEL 37702 SERIAL # (B)(4) DETERMINED THERE WAS NO ANOMALY FOUND WITH THE INS. THERE WAS FOREIGN MATERIAL UNDER THE COVER. GOOD, STABLE OUTPUT WAS OBSERVED ON ALL ELECTRODES REFERENCED TO ONE ELECTRODE. ANALYSIS OF EXTENSION MODEL 3708320 SERIAL # (B)(4) DETERMINED THERE WERE NO SIGNIFICANT ANOMALIES FOUND WITH THE EXTENSION. THE BODY INSULATION WAS CUT THROUGH (SUSPECTED EXPLANTED DAMAGE) AND THE EXTENSION WAS SEGMENTED. THE CONTINUITY WAS ACCEPTABLE AND GOOD, STABLE OUTPUT WAS REPORTED ON EACH ELECTRODE PAIRS REFERENCED TO ONE ELECTRODE. ANALYSIS OF LEAD MODEL 3986A70 LOT # N223405 DETERMINED NO SIGNIFICANT ANOMALY WAS FOUND. THE LEAD WAS CUT THROUGH AND PRODUCT WAS SEGMENTED (SUSPECTED EXPLANTED DAMAGE). THE CONTINUITY WAS ACCEPTABLE AND THERE WERE NO SHORTS BETWEEN CIRCUITS. THE OUTER INSULATION WAS MELTED AND THIS WAS SUSPECTED CAUTERY. ANALYSIS OF PLUG ACCESSORY SERIAL # UNKNOWN DETERMINED NO SIGNIFICANT ANOMALY WERE FOUND WITH THE PLUG. THE CONNECTOR LEG(S) WERE STRETCHED. EXTENSION MODEL 37083 SERIAL # (B)(4) IMPLANTED: (B)(6) 2011. EXPLANTED: (B)(6) 2011. LEAD MODEL 3986A LOT # N223405 IMPLANTED: UNK EXPLANTED: (B)(6) 2011 PLUG ACCESSORY MODEL UNK IMPLANTED: UNK EXPLANTED: UNK PATIENT PROGRAMMER MODEL 37743 SERIAL # (B)(4) IMPLANTED: NA EXPLANTED: NA.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE WAS EXPLANTED (B)(6) 2011 BECAUSE THE DEVICE WAS NOT HELPING THE PATIENT. ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT DEVELOPED A SPINAL CORD INJURY DURING SURGICAL PLACEMENT. THE LEAD NARROWED THE CANAL WHICH CAUSED STENOSIS. SYMPTOMS ASSOCIATED WITH THE EVENT INCLUDED NEUROPATHIC PAIN AND WEAKNESS IN CHEST ON DOWN POST-OPERATIVELY FOLLOWING THE INITIAL PLACEMENT. THE PATIENT REQUIRED HOSPITALIZATION AFTER THE ORIGINAL PLACEMENT. THERE WAS A NON-SERIOUS INJURY/ILLNESS AND THERE WAS SIGNIFICANT IMPROVEMENT AFTER INITIAL INJURY.

    Description of Event or Problem · 1

    FURTHER FOLLOW-UP INFORMATION RECEIVED CONFIRMED THAT THE EVENT WAS DUE TO THE SPINAL CANAL BEING TOO SMALL FOR THE LEAD AND CLARIFIED THAT THE HOSPITALIZATION OCCURRED FOR THE EXPLANTATION OF THE DEVICE ONLY (HEALTHCARE PROFESSIONAL COULD NOT PROVIDE FURTHER DETAILS). THE PATIENT OUTCOME RELATED TO THE SPINAL CORD INJURY WAS REPORTED AS PERMANENT WEAKNESS, NUMBNESS, AND PAIN. 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 MDT PUERTO RICO OPERATIONS CO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR Hospitalization| R| S