BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 8857740 · Received August 2, 2019

    Report

    Report Number
    3006630150-2019-04001
    Event Type
    Injury
    Date Received
    August 2, 2019
    Date of Event
    June 28, 2019
    Report Date
    August 27, 2019
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT AN IPG EXPLANT PROCEDURE AND LEAD WAS KEPT IN PLACE TO HOLD SPACE FOR A FUTURE IMPLANT. IT WAS MENTIONED THAT THE INCISION SITES WERE LEAKING A FLUID, BUT NO OBVIOUS INFECTION WAS NOTED. IT WAS ALSO MENTIONED THAT THE BUBBLE TISSUE AT THE CERVICAL INCISION SITE WAS FILLED WITH A COIL OF LEAD THAT APPEARED TO BE WORKING ITS WAY OUT OF THE INCISION. THE WOUNDS WERE IRRIGATED WITH ANTIBIOTIC SOLUTION AND CLOSED. THE PATIENT WAS TREATED WITH ANTIBIOTICS AND WAS REPORTEDLY DOING WELL POSTOPERATIVELY. MODEL NUMBER/CATALOG NUMBER: SC-8336-70, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 7023411, MODEL/CATALOG DESCRIPTION : COVERAGE 32 SURGICAL LEAD KIT 70 CM. THE EXPLANTED DEVICE WAS NOT RETURNED TO BSN. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE IPG AND LEAD REVEALED THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATE TO THE EVENT OCCURRED DURING MANUFACTURING. A REVIEW OF THE STERILIZATION DOCUMENTATION FOR THE IPG AND LEAD WAS FOUND TO BE SATISFACTORY.

    Description of Event or Problem · 0

    A REPORT WAS RECEIVED THAT PATIENT HAD A BUBBLE ON HIS NECK THAT MIGHT BE A BLISTER OR FROM SPINAL FLUID LEAK FROM THE LITTLE HOLE THAT WAS CAUSED FROM HIS LAST SURGERY (MFR REPORT NUMBER: 3006630150-2019-00969).

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT PATIENT HAD A BUBBLE ON HIS NECK THAT MIGHT BE A BLISTER OR FROM SPINAL FLUID LEAK FROM THE LITTLE HOLE THAT WAS CAUSED FROM HIS LAST SURGERY (MFR REPORT NUMBER: 3006630150-2019-00969).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649736 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 347578 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention