BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALGOVITA SPINAL CORD STIMULATION

    MDR report key: 5779044 · Received July 8, 2016

    Report

    Report Number
    3010309840-2016-00007
    Event Type
    Injury
    Date Received
    July 8, 2016
    Date of Event
    June 16, 2016
    Report Date
    June 16, 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). 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".

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO THE MANUFACTURER THAT A PATIENT HAD EXPERIENCED AN ABSCESS DURING THE TRIAL PHASE. THE PATIENT UNDERWENT AN IMPLANT OF TRIAL SYSTEM ON THE (B)(6) 2016. THE PATIENT'S TRIAL WAS SUCCESSFUL FOR 2 DAYS AT WHICH TIME THE PATIENT REPORTED THAT THE SYSTEM WAS NO LONGER DELIVERING THERAPY. THE SPOUSE OF THE PATIENT PROCEEDED TO REMOVE THE TEGADERM BANDAGE AND TOOK PICTURES OF THE IMPLANT SITE. THE SALES REPRESENTATIVE ADVISED THE PATIENT TO BE SEEN BY THE IMPLANTING PHYSICIAN. THE PATIENT RETURNED TO THE PHYSICIAN'S OFFICE ON THE (B)(6) AND SYSTEM WAS EXPLANTED. THE PATIENT DEVELOPED ABSCESS 7 DAYS POST IMPLANT. THE ABSCESS WAS TREATED THERE HAVE BEEN NO FURTHER REPORTED ADVERSE EVENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED TO THE MANUFACTURER THAT A PATIENT HAD EXPERIENCED AN ABSCESS DURING THE TRIAL PHASE. THE PATIENT UNDERWENT AN IMPLANT OF TRIAL SYSTEM ON THE (B)(6) 2016. THE PATIENT'S TRIAL WAS SUCCESSFUL FOR 2 DAYS AT WHICH TIME THE PATIENT REPORTED THAT THE SYSTEM WAS NO LONGER DELIVERING THERAPY. THE SPOUSE OF THE PATIENT PROCEEDED TO REMOVE THE TEGADERM BANDAGE AND TOOK PICTURES OF THE IMPLANT SITE. THE SALES REPRESENTATIVE ADVISED THE PATIENT TO BE SEEN BY THE IMPLANTING PHYSICIAN. THE PATIENT RETURNED TO THE PHYSICIAN'S OFFICE ON THE (B)(6) AND SYSTEM WAS EXPLANTED. THE PATIENT DEVELOPED ABSCESS 7 DAYS POST IMPLANT. THE ABSCESS WAS TREATED THERE HAVE BEEN NO FURTHER REPORTED ADVERSE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433247 ALGOVITA SPINAL CORD STIMULATION STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED (PAIN RELIEF) LGW NUVECTRA 1084-60T

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention