BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION SPECTRA

    MDR report key: 8903609 · Received August 16, 2019

    Report

    Report Number
    3006630150-2019-04352
    Event Type
    Injury
    Date Received
    August 16, 2019
    Date of Event
    July 25, 2019
    Report Date
    August 16, 2019
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729821526
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: (B)(6). MODEL NUMBER/CATALOG NUMBER: SC-1110, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 101838, MODEL/CATALOG DESCRIPTION:SCS IPG2 DUAL ARRAY RECHARGABLE IPG. MODEL NUMBER/CATALOG NUMBER: SC-2138-70, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 111893/119890, MODEL/CATALOG DESCRIPTION: PHASE III LINEAR LEAD - 70CM. MODEL NUMBER/CATALOG NUMBER: SC-2316-50, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 15813556/15960103, MODEL/CATALOG DESCRIPTION: INFINION 16 LEAD KIT 50 CM. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE DEVICES REVEALED THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATE TO THE EVENT OCCURRED DURING MANUFACTURING.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE FOR AN UNKNOWN REASON. NO FURTHER INFORMATION COULD BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696450 PRECISION SPECTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1132 16113957 08714729821526

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention