BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALGOVITA SPINAL CORD STIMULATION

    MDR report key: 5831495 · Received July 28, 2016

    Report

    Report Number
    3010309840-2016-00008
    Event Type
    Injury
    Date Received
    July 28, 2016
    Date of Event
    June 30, 2016
    Report Date
    June 30, 2016
    Manufacturer
    NUVECTRA
    Product Code
    LGW
    PMA / PMN Number
    P130028
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). MANUFACTURE REFERENCE NUMBER IS (B)(4). CORRECTIONS: COMMON DEVICE NAME: CHANGED FROM "STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)" TO "STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED (PAIN RELIEF)". PRODUCT CODE: CHANGED FROM "GZB" TO "LGW".

    Description of Event or Problem · 1

    PATIENT UNDERWENT A BILATERAL SPINAL CORD STIMULATION TRIAL PROCEDURE UTILIZING THE ALGOVITA SPINAL CORD STIMULATION (SCS) TRIAL SYSTEM WITH TWO PERCUTANOUS 1084-60T, 8-ELECTRODE LEADS, (B)(6) 2016. THE PATIENT SUCCESSFULLY COMPLETED THE TRIAL WITH EXCELLENT PAIN RELIEF AND THE LEADS WERE EXTRACTED, (B)(6) 2016. THE FIRST LEAD WAS REMOVED ROUTINELY. THE HEALTH CARE PROFESSIONAL REPORTED RESISTANCE DURING EXTRACTION OF THE SECOND PERCUTANEOUS LEAD. ONCE THE LEAD WAS FREE OF THE PATIENT, IT WAS DETERMINED THAT THE DISTAL ELECTRODE PORTION OF THE PERCUTANEOUS LEAD REMAINED IN THE PATIENT. THE PATIENT WAS PLACED ON AN ANTIBIOTIC REGIMEN AND BANDAGE WAS PLACED OVER THE IMPLANT SITE. BECAUSE THE TRIAL PROCEDURE WAS DEEMED SUCCESSFUL, THE PATIENT WAS SCHEDULED FOR A PERMANENT SCS IMPLANT. THE PATIENT UNDERWENT THE PROCEDURE FOR A PERMANENT SCS SYSTEM IMPLANT ON (B)(6) 2016. DURING THE PROCEDURE, THE PERCUTANEOUS LEAD FRAGMENT WAS EASILY REMOVED FROM THE EPIDURAL SPACE WITHOUT INCIDENT, AND A SURGICAL / PADDLE LEAD WAS SUCCESSFULLY PLACED. THERE WERE NO ADDITIONAL SURGICAL OR PATIENT COMPLICATIONS NOTED AND THE PATIENT'S POST-OPERATIVE STATUS HAS BEEN REPORTED AS FINE.

    Description of Event or Problem · 1

    PATIENT UNDERWENT A BILATERAL SPINAL CORD STIMULATION TRIAL PROCEDURE UTILIZING THE ALGOVITA SPINAL CORD STIMULATION (SCS) TRIAL SYSTEM WITH TWO PERCUTANOUS1084-60T, 8-ELECTRODE LEADS, (B)(6) 2016. THE PATIENT SUCCESSFULLY COMPLETED THE TRIAL WITH EXCELLENT PAIN RELIEF AND THE LEADS WERE EXTRACTED, (B)(6) 2016. THE FIRST LEAD WAS REMOVED ROUTINELY. THE HEALTH CARE PROFESSIONAL REPORTED RESISTANCE DURING EXTRACTION OF THE SECOND PERCUTANEOUS LEAD. ONCE THE LEAD WAS FREE OF THE PATIENT, IT WAS DETERMINED THAT THE DISTAL ELECTRODE PORTION OF THE PERCUTANEOUS LEAD REMAINED IN THE PATIENT. THE PATIENT WAS PLACED ON AN ANTIBIOTIC REGIMEN AND BANDAGE WAS PLACED OVER THE IMPLANT SITE. BECAUSE THE TRIAL PROCEDURE WAS DEEMED SUCCESSFUL, THE PATIENT WAS SCHEDULED FOR A PERMANENT SCS IMPLANT. THE PATIENT UNDERWENT THE PROCEDURE FOR A PERMANENT SCS SYSTEM IMPLANT ON (B)(6) 2016. DURING THE PROCEDURE, THE PERCUTANEOUS LEAD FRAGMENT WAS EASILY REMOVED FROM THE EPIDURAL SPACE WITHOUT INCIDENT, AND A SURGICAL / PADDLE LEAD WAS SUCCESSFULLY PLACED. THERE WERE NO ADDITIONAL SURGICAL OR PATIENT COMPLICATIONS NOTED AND THE PATIENT'S POST-OPERATIVE STATUS HAS BEEN REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    481138 ALGOVITA SPINAL CORD STIMULATION STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED (PAIN RELIEF) LGW NUVECTRA 1084-60T

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention