BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY VERSITREL

    MDR report key: 2844209 · Received November 26, 2012

    Report

    Report Number
    6000032-2012-00204
    Event Type
    Injury
    Date Received
    November 26, 2012
    Report Date
    October 30, 2012
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3889-33, EXPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD. FINAL ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (INS) FOUND NO SIGNIFICANT ANOMALY. THE INS WAS NOT IN NEW CONDITION. FINAL ANALYSIS OF EXTENSION (SERIAL # (B)(4)) FOUND NO ANOMALY. FINAL ANALYSIS OF EXTENSION (SERIAL # (B)(4)) FOUND NO ANOMALY. FINAL ANALYSIS OF LEAD (LOT # J0120545V) FOUND THE CONDUCTOR WAS BROKEN AT UNKNOWN ANCHOR SITE. FINAL ANALYSIS OF LEAD (PRODUCT # 3889-33) FOUND CONDUCTOR WAS BROKEN AT OR NEAR TINES.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    PRODUCT ID NEU_UNKNOWN_LEAD, EXPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 7495LZ25, SERIAL # (B)(4), IMPLANTED: (B)(6) 2002, EXPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION; PRODUCT ID 748910, SERIAL # (B)(4), EXPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION; PRODUCT ID 7435, SERIAL # (B)(4), IMPLANTED: (B)(6) 2002, PRODUCT TYPE PROGRAMMER; PATIENT PRODUCT ID (B)(4), LOT # J0120545V, IMPLANTED: (B)(6) 2002, EXPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PATIENT HAD THEIR IMPLANTABLE NEUROSTIMULATOR (INS) EXPLANTED ON (B)(6) 2012 FOR UNKNOWN REASONS. FOLLOW UP INFORMATION RECEIVED REPORTED THAT THE REASON FOR THE REMOVAL OF THE INS AND LEAD WAS THAT THE PATIENT NO LONGER HAD BENEFICIAL THERAPY AND THAT THEY NEEDED AN MRI. FURTHER FOLLOW UP INFORMATION RECEIVED FROM THE PHYSICIAN INDICATED THAT THERE WERE NO DEVICES ISSUES AND THAT THE INS WAS WORKING WELL. THE PHYSICIAN ALSO CONFIRMED THAT THE PATIENT NEEDED, AT THE REQUEST OF THEIR NEUROLOGIST, AN MRI OF THE SHOULDER. THE EXPLANTED PROCEDURE WAS UNEVENTFUL AND THAT PATIENT OUTCOME WAS REPORTED AS NO INJURY. NOTE: MANUFACTURERS DEVICE REGISTRY NOTES A DATE OF (B)(6) 2012 FOR REMOVAL OF THE INS SYSTEM.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATED THE PATIENT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNERGY VERSITREL STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT SOFAMOR DANEK PUERTO RICO MFG 7427V

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention