BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1995935 · Received January 21, 2011

    Report

    Report Number
    3006630150-2011-00102
    Event Type
    Injury
    Date Received
    January 21, 2011
    Date of Event
    December 22, 2010
    Report Date
    December 28, 2010
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE. THE PATIENT'S IPG WAS REPLACED ON (B)(6) 2011. THE PADDLE LEAD REMAINS IMPLANTED IN THE PATIENT. THE PATIENT IS REPORTEDLY DOING WELL.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT'S SHOCKING SENSATION WAS BELIEVED TO BE CAUSED BY THE PADDLE LEAD TUGGING AT SCAR TISSUE. PRODUCT ANALYSIS FOR IPG (S/N (B)(4)) INDICATED THAT THE COMPLAINT OF OVERSTIMULATION WAS NOT CONFIRMED. HOWEVER, REVIEW OF BATTERY PROFILE INDICATED THAT MAXIMUM BATTERY DEPLETION RATE AFTER EXPLANT DATE WAS 26.8 MV PER DAY WITH THE STIMULATION TURNED OFF, WHICH IS BEYOND THE EXPECTED RANGE. THE AIC-U1 DAMAGE RESULTED IN THE ABNORMAL BATTERY DEPLETION RATE OF THE IPG. 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 (B)(4)).

    Additional Manufacturer Narrative · 1

    ADD'L SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #- SC-1110-02, SERIAL #- (B)(4), DESCRIPTION - IPG KIT (WITHOUT PULL-THROUGH TUNNELER).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WILL NOT UNDERGO A REVISION. THE PHYSICIAN INDICATED THAT HE DOES NOT KNOW WHAT THE PROBLEM IS SO THERE IS NO SENSE OF URGENCY. BSN WILL BE NOTIFIED IF OR WHEN THE REVISION WILL TAKE PLACE. A REVIEW OF THE MANUFACTURING DOCUMENTATION OF THE DEVICES FOUND THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT WHEN THE STIMULATION IS ON THE PATIENT FEELS SHOCKING SENSATIONS DURING POSTURAL CHANGES AND ALSO WHEN THE IPG IS PALPATED. THE PATIENT ALSO REPORTED RAPID BATTERY DEPLETION AFTER RECENTLY UNDERGOING A PULSED RF PROCEDURE. A BSN FIELD CLINICAL ENGINEER (FCE) MET WITH THE PATIENT AND ANALYZED THE DEVICE AND DETERMINED THE CAUSE OF THE SENSATIONS WERE THE PADDLE LEAD. REPROGRAMMING WAS NOT SUCCESSFUL AND A REVISION SURGERY IS NOW RECOMMENDED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT WHEN THE STIMULATION IS ON THE PATIENT FEELS SHOCKING SENSATIONS DURING POSTURAL CHANGES AND ALSO WHEN THE IPG IS PALPATED. THE PATIENT ALSO REPORTED RAPID BATTERY DEPLETION AFTER RECENTLY UNDERGOING A PULSED RF PROCEDURE. A BSN FIELD CLINICAL ENGINEER (FCE) MET WITH THE PATIENT AND ANALYZED THE DEVICE AND DETERMINED THE CAUSE OF THE SENSATIONS WERE THE PADDLE LEAD. REPROGRAMMING WAS NOT SUCCESSFUL AND A REVISION SURGERY IS NOW RECOMMENDED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT WHEN THE STIMULATION IS ON THE PATIENT FEELS SHOCKING SENSATIONS DURING POSTURAL CHANGES AND ALSO WHEN THE IPG IS PALPATED. THE PATIENT ALSO REPORTED RAPID BATTERY DEPLETION AFTER RECENTLY UNDERGOING A PULSED RF PROCEDURE. A BSN FIELD CLINICAL ENGINEER (FCE) MET WITH THE PATIENT AND ANALYZED THE DEVICE AND DETERMINED THE CAUSE OF THE SENSATIONS WERE THE PADDLE LEAD. REPROGRAMMING WAS NOT SUCCESSFUL AND A REVISION SURGERY IS NOW RECOMMENDED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT WHEN THE STIMULATION IS ON, THE PT FEELS SHOCKING SENSATIONS DURING POSTURAL CHANGES AND ALSO WHEN THE IPG IS PALPATED. THE PT ALSO REPORTED RAPID BATTERY DEPLETION AFTER RECENTLY UNDERGOING A PULSED RF PROCEDURE. A BSN FIELD CLINICAL ENGINEER (FCE) MET WITH THE PT AND ANALYZED THE DEVICE AND DETERMINED THE CAUSE OF THE SENSATIONS WERE THE PADDLE LEAD. REPROGRAMMING WAS NOT SUCCESSFUL AND A REVISION SURGERY IS NOW RECOMMENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-8120-70 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention