BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 3012852 · Received March 20, 2013

    Report

    Report Number
    3006630150-2013-00421
    Event Type
    Injury
    Date Received
    March 20, 2013
    Date of Event
    February 14, 2013
    Report Date
    February 18, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WILL NO LONGER UNDERGO THE REVISION PROCEDURE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-3138-55, SERIAL/LOT#: (B)(4), DESCRIPTION: SCS PHIII EXT 55CM. THE RETURNED PRODUCT ANALYSIS CONFIRMED THE COMPLAINT REGARDING THE IPG. THE IPG PASSED ELECTRICAL AND PHOTOGRAPHIC TESTS PERFORMED. THE IPG SHOWED SIGNS OF ANALOG IC DAMAGE DUE TO A HIGH VOLTAGE TRANSIENT. THE IPG EXHIBITED PREMATURE BATTERY DEPLETION, EXCESSIVE SLEEP CURRENT LEAKAGE AND LOW IMPEDANCES. IT WAS REPORTED THAT DURING THE PROCEDURE ELECTROCAUTERY WAS USED AND THE DEVICE HAD BEEN AFFECTED BY IT. A REVIEW OF THE STERILIZATION RECORD DID NOT FIND ANY ANOMALIES OR DEVIATIONS THAT POTENTIALLY RELATE TO THE REPORTED INFECTION. THE RETURNED PRODUCT ANALYSIS FOR THE LEAD EXTENSION SHOWED THAT THE EXTENSIONS PASSED PHOTOGRAPHIC IMAGING TESTS. BOTH LEAD BODIES WERE CLEANLY CUT AND ONLY THE PROXIMAL ENDS WERE RETURNED. DAMAGES TO THE LEAD EXTENSIONS IS A RESULT OF THE TYPICAL EXPLANT PROCEDURE AND IS NOT CONSIDERED A FAILURE. A REVIEW OF THE STERILIZATION RECORD FOR THE LEAD EXTENSIONS DID NOT FIND ANY ANOMALIES OR DEVIATIONS THAT POTENTIALLY RELATE TO THE REPORTED INFECTION.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT HAD THE IPG EXPLANTED DUE TO INFECTION. THE PATIENT WAS EXPERIENCING PUS AND REDNESS AROUND THE IPG SITE. THE PATIENT WAS PROVIDED WITH ANTIBIOTICS. THE PHYSICIAN DOES NOT BELIEVE THE INFECTION IS DEVICE RELATED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT FOLLOWING A REVISION THE PATIENT WAS HAVING DIFFICULTY CHARGING THE IPG. IT WAS REPORTED THAT ELECTROCAUTERY WAS USED DURING THE REVISION. THE PATIENT WILL UNDERGO AN IPG REPLACEMENT. MONOPOLAR ELECTROCAUTERY IS A KNOWN SOURCE OF HIGH VOLTAGE TRANSIENT SIGNAL AND CURRENT COMPANY LABELING WARNS AGAINST THE USE OF MONOPOLAR ELECTROCAUTERY. (PHYSICIAN¿S IMPLANT MANUAL 9055940-001).

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT FOLLOWING A REVISION THE PATIENT WAS HAVING DIFFICULTY CHARGING THE IPG. IT WAS REPORTED THAT ELECTROCAUTERY WAS USED DURING THE REVISION. THE PATIENT WILL UNDERGO AN IPG REPLACEMENT. MONOPOLAR ELECTROCAUTERY IS A KNOWN SOURCE OF HIGH VOLTAGE TRANSIENT SIGNAL AND CURRENT COMPANY LABELING WARNS AGAINST THE USE OF MONOPOLAR ELECTROCAUTERY. ((B)(4)).

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT FOLLOWING A REVISION THE PATIENT WAS HAVING DIFFICULTY CHARGING THE IPG. IT WAS REPORTED THAT ELECTROCAUTERY WAS USED DURING THE REVISION. THE PATIENT WILL UNDERGO AN IPG REPLACEMENT. MONOPOLAR ELECTROCAUTERY IS A KNOWN SOURCE OF HIGH VOLTAGE TRANSIENT SIGNAL AND CURRENT COMPANY LABELING WARNS AGAINST THE USE OF MONOPOLAR ELECTROCAUTERY. (PHYSICIAN¿S IMPLANT MANUAL 9055940-001).

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT FOLLOWING A REVISION THE PATIENT WAS HAVING DIFFICULTY CHARGING THE IPG. IT WAS REPORTED THAT ELECTROCAUTERY WAS USED DURING THE REVISION. THE PATIENT WILL UNDERGO AN IPG REPLACEMENT. MONOPOLAR ELECTROCAUTERY IS A KNOWN SOURCE OF HIGH VOLTAGE TRANSIENT SIGNAL AND CURRENT COMPANY LABELING WARNS AGAINST THE USE OF MONOPOLAR ELECTROCAUTERY. (PHYSICIAN'S IMPLANT MANUAL 9055940-001).

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT FOLLOWING A REVISION THE PATIENT WAS HAVING DIFFICULTY CHARGING THE IPG. IT WAS REPORTED THAT ELECTROCAUTERY WAS USED DURING THE REVISION. THE PATIENT WILL UNDERGO AN IPG REPLACEMENT. MONOPOLAR ELECTROCAUTERY IS A KNOWN SOURCE OF HIGH VOLTAGE TRANSIENT SIGNAL AND CURRENT COMPANY LABELING WARNS AGAINST THE USE OF MONOPOLAR ELECTROCAUTERY. (PHYSICIAN'S IMPLANT MANUAL 9055940-001)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116551 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention