BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1950185 · Received December 10, 2010

    Report

    Report Number
    3006630150-2010-02104
    Event Type
    Injury
    Date Received
    December 10, 2010
    Date of Event
    November 10, 2010
    Report Date
    November 10, 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
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT A GOOD FAITH EFFORT WAS MADE TO FOLLOW UP WITH THE PATIENT REGARDING THE IPG DISCOMFORT DUE TO THE IPG BEING SLANTED. THE EFFORT WAS UNSUCCESSFUL.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT DURING THE REVISION SURGERY, THE PHYSICIAN EXPLANTED ONE OF THE PADDLE LEADS AND ONE LEAD EXTENSION. THE PHYSICIAN NOTICED THAT THE ELECTRODES WERE LOOSE ON THE PADDLE LEAD. ALL THE CONTACTS WERE RETRIEVED FROM THE PATIENT. THE EXPLANTED LEAD EXTENSION WAS NOT RETURNED. THE PHYSICIAN DID NOT SUSPECT ANY MALFUNCTION. THE MECHANICAL CONNECTION PROBLEM BETWEEN THE PADDLE LEAD AND EXTENSION, THAT WAS SUSPECTED BY THE PHYSICIAN, COULD NOT BE TESTED AS THE EXTENSION WAS NOT RETURNED TO BSN. VISUAL INSPECTION OF PADDLE LEAD ((B)(4)) REVEALED THAT THE LEAD WAS CUT APPROXIMATELY 8 CM FROM THE PADDLE END. ELECTRODES NUMBER 4, 5, 8, 12, 13 AND 16 WERE DISLODGED FROM PADDLE END, BUT WERE STILL ATTACHED AT THE CABLE. THE DAMAGE TO THE PADDLE LEAD IS CONSISTENT WITH DAMAGES DONE DURING THE EXPLANT PROCEDURE AND ARE NOT CONSIDERED A FAILURE. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE LEAD EXTENSIONS REVEALED THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PT WAS NOT RECEIVING ADEQUATE THERAPY TO COVER HER PAIN. A BSN FIELD CLINICAL ENGINEER (FCE) MET WITH THE PT AND DETERMINED THAT ONE OF THE CONTACTS NOT BEING USED IN THE PT'S CURRENT PROGRAMS IS EXHIBITING HIGH IMPEDANCES. THE BSN FCE BELIEVES THERE MAY BE A CONNECTION ISSUE BETWEEN THE LEAD AND LEAD EXTENSION. THE IPG WAS ALSO SLANTED IN THE POCKET CAUSING THE PT DISCOMFORT. THE IPG WAS FUNCTIONING PROPERLY. THE BSN FCE RECOMMENDED THAT THE LEAD BE REPLACED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS NOT RECEIVING ADEQUATE THERAPY TO COVER HER PAIN. A BSN FIELD CLINICAL ENGINEER (FCE) MET WITH THE PATIENT AND DETERMINED THAT ONE OF THE CONTACTS NOT BEING USED IN THE PATIENT'S CURRENT PROGRAMS IS EXHIBITING HIGH IMPEDENCES. THE BSN FCE BELIEVES THERE MAY BE A CONNECTION ISSUE BETWEEN THE LEAD AND LEAD EXTENSION. THE IPG WAS ALSO SLANTED IN THE POCKET CAUSING THE PATIENT DISCOMFORT. THE IPG WAS FUNCTIONING PROPERLY. THE BSN FCE RECOMMENDED THAT THE LEAD BE REPLACED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS NOT RECEIVING ADEQUATE THERAPY TO COVER HER PAIN. A BSN FIELD CLINICAL ENGINEER (FCE) MET WITH THE PATIENT AND DETERMINED THAT ONE OF THE CONTACTS NOT BEING USED IN THE PATIENT'S CURRENT PROGRAMS IS EXHIBITING HIGH IMPEDENCES. THE BSN FCE BELIEVES THERE MAY BE A CONNECTION ISSUE BETWEEN THE LEAD AND LEAD EXTENSION. THE IPG WAS ALSO SLANTED IN THE POCKET CAUSING THE PATIENT DISCOMFORT. THE IPG WAS FUNCTIONING PROPERLY. THE BSN FCE RECOMMENDED THAT THE LEAD BE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION SPINAL CORD CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-8116-70 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Required Intervention LEAD EXTENSION, 35 CM: MODEL # SC-3138-35| ARTISAN 2X8 PADDLE LEAD, 70 CM: MODEL # SC-8116-70| SERIAL #: (B)(4)| SERIAL #: (B)(4)| IMPLANTABLE PULSE GENERATOR (IPG): MODEL # SC-1110| SERIAL #: (B)(4)| SERIAL #: (B)(4)