BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 2221652 · Received August 24, 2011

    Report

    Report Number
    3006630150-2011-01273
    Event Type
    Injury
    Date Received
    August 24, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 5, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED INDICATED THAT THE PATIENT UNDERWENT A IPG REPLACEMENT PROCEDURE. THE PHYSICIAN REPLACED PATIENT'S IPG AND THE PATIENT IS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT INDICATED THAT THE PATIENT WILL NOT UNDERGO IPG REPLACEMENT AT THIS TIME DUE TO NON-DEVICE RELATED MEDICAL ISSUES. A REVIEW OF THE MANUFACTURING DOCUMENTATION OF THE DEVICE FOUND THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WAS CONFIRMED BY THE ANALYSIS OF THE EXPLANTED IPG. THE DEVICE EXHIBITED PREMATURE BATTERY DEPLETION AND THE CHARACTERISTICS OF ANALOG IC DAMAGE DUE TO HIGH-VOLTAGE TRANSIENTS. THE MONOPOLAR ELECTROCAUTERY PROCEDURES ARE A KNOWN SOURCE OF HIGH-VOLTAGE TRANSIENT SIGNAL THAT CAN DAMAGE THE AIC-U1. CURRENT LABELING WARNS AGAINST THE USE OF MONOPOLAR ELECTROCAUTERY (REFER TO PHYSICIAN'S IMPLANT MANUAL 9055940-001).

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT HE HAD TO CHARGE MORE OFTEN THAN USUAL. THE DATABASE ANALYSIS EXHIBITED PREMATURE BATTERY DEPLETION. THE PHYSICIAN HAS DECIDED TO REPLACE THE PATIENT'S IPG.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT HE HAD TO CHARGE MORE OFTEN THAN USUAL. THE DATABASE ANALYSIS EXHIBITED PREMATURE BATTERY DEPLETION. THE PHYSICIAN HAS DECIDED TO REPLACE THE PATIENT'S IPG.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT HE HAD TO CHARGE MORE OFTEN THAN USUAL. THE DATABASE ANALYSIS EXHIBITED PREMATURE BATTERY DEPLETION. THE PHYSICIAN HAS DECIDED TO REPLACE THE PATIENT'S IPG.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT HE HAD TO CHARGE MORE OFTEN THAN USUAL. THE DATABASE ANALYSIS EXHIBITED PREMATURE BATTERY DEPLETION. THE PHYSICIAN HAS DECIDED TO REPLACE THE PATIENT'S IPG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention