BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION SPECTRA®

    MDR report key: 6332781 · Received February 15, 2017

    Report

    Report Number
    3006630150-2017-00457
    Event Type
    Injury
    Date Received
    February 15, 2017
    Date of Event
    December 28, 2016
    Report Date
    February 6, 2018
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729821526
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WILL BE NO FURTHER COURSE OF ACTION AT THIS TIME.

    Additional Manufacturer Narrative · 1

    CORRECTION TO THE FU #2. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-2317-70 SERIAL #: (B)(4)DESCRIPTION: INFINION CX 70 CM LEAD.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WILL UNDERGO AN EXPLANT PROCEDURE. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-2317-70 SERIAL #: 3113401/3113402 DESCRIPTION: INFINION CX 70 CM LEAD.

    Additional Manufacturer Narrative · 1

    SC-1132 (B)(4) DEVICE EVALUATION INDICATED THAT THE RETURNED IPG PASSED ALL THE REQUIRED TESTS AND REVEALED NO ANOMALIES. SC-2137-70 (B)(4) DEVICE EVALUATION INDICATED THAT THE LEAD EXHIBITED CABLE FRACTURES IN THE PROXIMAL END (E7, E8). HOWEVER, THESE CONTACTS HAVE NOT BEEN UTILIZED ON STIMULATION SETTING. SC-2137-70 (B)(4) DEVICE EVALUATION INDICATED THAT THE LEAD EXHIBITED CABLE FRACTURES IN THE PROXIMAL ENDS (E7, E12, AND E16). THESE CONTACTS APPEARED TO BE UTILIZED ON STIMULATION SETTING, WHICH COULD BE THE SOURCE OF THE INEFFECTIVE THERAPY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT PATIENT HAD UNCLEAR REACTION TO THE IPG HEADER DISC. SYMPTOM WAS ITCHING AFTER SCS IMPLANT. IT WAS ALSO NOTED THAT PATIENT'S IPG SITE WAS TENDER TO TOUCH. THE PATIENT WAS PRESCRIBED WITH CLARITIN.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT PATIENT HAD UNCLEAR REACTION TO THE IPG HEADER DISC. SYMPTOM WAS ITCHING AFTER SCS IMPLANT. IT WAS ALSO NOTED THAT PATIENT'S IPG SITE WAS TENDER TO TOUCH. THE PATIENT WAS PRESCRIBED WITH CLARITIN.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT PATIENT HAD UNCLEAR REACTION TO THE IPG HEADER DISC. SYMPTOM WAS ITCHING AFTER SCS IMPLANT. IT WAS ALSO NOTED THAT PATIENT'S IPG SITE WAS TENDER TO TOUCH. THE PATIENT WAS PRESCRIBED WITH CLARITIN.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT PATIENT HAD UNCLEAR REACTION TO THE IPG HEADER DISC. SYMPTOM WAS ITCHING AFTER SCS IMPLANT. IT WAS ALSO NOTED THAT PATIENT'S IPG SITE WAS TENDER TO TOUCH. THE PATIENT WAS PRESCRIBED WITH CLARITIN.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT PATIENT HAD UNCLEAR REACTION TO THE IPG HEADER DISC. SYMPTOM WAS ITCHING AFTER SCS IMPLANT. IT WAS ALSO NOTED THAT PATIENT'S IPG SITE WAS TENDER TO TOUCH. THE PATIENT WAS PRESCRIBED WITH CLARITIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116544 PRECISION SPECTRA® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1132 NA 08714729821526

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention