BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2203110 · Received August 11, 2011

    Report

    Report Number
    3006630150-2011-01209
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    July 6, 2011
    Report Date
    July 6, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL#: SC-2352-50, (B)(4) AND (B)(4), MODEL DESCRIPTION: LINEAR 3-4 LEAD 50CM. THE EXPLANTED LEADS WERE NOT RETURNED TO BSN FOR EVALUATION AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

    Additional Manufacturer Narrative · 1

    A RETURNED PRODUCT ANALYSIS INDICATED THAT THE COMPLAINT OF THE PREMATURE BATTERY DEPLETION OF THE IPG HAS BEEN CONFIRMED. THE ANALOG IC (AIC-U1) WAS DAMAGED. THE BATTERY DEPLETION RATE EXCEEDS THE TYPICAL BATTERY DEPLETION RATE. MONOPOLAR ELECTROCAUTERY IS A KNOWN SOURCE OF HIGH-VOLTAGE TRANSIENT SIGNAL AND CURRENT LABELING WARNS AGAINST THE USE OF MONOPOLAR ELECTROCAUTERY (REFER TO PHYSICIAN'S IMPLANT MANUAL).

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS HAVING DIFFICULTY KEEPING THE IPG CHARGED. A BSN ENGINEER CONFIRMED THAT THE DEVICE EXHIBITS PREMATURE BATTERY DEPLETION. THE PATIENT HAD THE IPG REPLACED AND DURING THE PROCEDURE THE PHYSICIAN ALSO REPLACED THE PATIENT'S LEADS. THE LEADS HAD BEEN CAUSING DISCOMFORT DUE TO THEIR LOCATION.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS HAVING DIFFICULTY KEEPING THE IPG CHARGED. A BSN ENGINEER CONFIRMED THAT THE DEVICE EXHIBITS PREMATURE BATTERY DEPLETION. THE PATIENT HAD THE IPG REPLACED AND DURING THE PROCEDURE THE PHYSICIAN ALSO REPLACED THE PATIENT'S LEADS. THE LEADS HAD BEEN CAUSING DISCOMFORT DUE TO THEIR LOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention