BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1901616 · Received November 12, 2010

    Report

    Report Number
    3006630150-2010-01962
    Event Type
    Injury
    Date Received
    November 12, 2010
    Date of Event
    September 3, 2010
    Report Date
    October 15, 2010
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MFG DOCUMENTATION FOR THE EXPLANTED DEVICES REVEALED THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING.

    Additional Manufacturer Narrative · 1

    CORRECTION TO MDR F/U #1 SHOULD HAVE BEEN: ADDITIONAL INFORMATION WAS RECEIVED THAT THE SCAR TISSUE WAS AROUND THE LEAD SITE AND NOT AT THE IPG SITE. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE EXPLANTED DEVICES 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 A PATIENT'S SYSTEM WAS EXPLANTED. THE PATIENT HAD EXPERIENCED PAIN AND LOST FEELING IN HIS LEGS AFTER SCAR TISSUE HAD FORMED AROUND THE IPG, WHICH CAUSED COMPRESSION ON THE SPINAL CORD. THE PATIENT IS REPORTEDLY DOING WELL FOLLOWING THE EXPLANT PROCEDURE AND HAS REGAINED FEELING IN HIS LEGS.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A PATIENT'S SYSTEM WAS EXPLANTED. THE PATIENT HAD EXPERIENCED PAIN AND LOST FEELING IN HIS LEGS AFTER SCAR TISSUE HAD FORMED AROUND THE IPG, WHICH CAUSED COMPRESSION ON THE SPINAL CORD. THE PATIENT IS REPORTEDLY DOING WELL FOLLOWING THE EXPLANT PROCEDURE AND HAS REGAINED FEELING IN HIS LEGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-8216-50 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention ARTISAN SURGICAL LEAD WITH PLATNALOCK| MODEL #: SC-8216-50| SERIAL#: (B)(4)| TECHNOLOGY - 50 CM