BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1990813 · Received February 8, 2011

    Report

    Report Number
    3006630150-2011-00193
    Event Type
    Injury
    Date Received
    February 8, 2011
    Date of Event
    January 14, 2011
    Report Date
    January 17, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED IPG PASSED VISUAL AND PHOTOGRAPHIC IMAGING TESTS. THE ANALOG IC WAS OBSERVED TO BE DAMAGED DUE TO ELECTROCAUTERY. 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 (B)(4)).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PHYSICIAN REPLACED THE IPG UPON THE PATIENT'S REQUEST BECAUSE SHE REPORTED THAT SHE WAS HAVING TROUBLE CHARGING THE IPG. THERE WAS NOTHING WRONG WITH THE DEVICE AS IT WAS WORKING PROPERLY AND PROVIDING STIMULATION. THE PATIENT'S TREATMENT WAS ADMINISTERED FOR AN UNRELATED CONDITION AND WAS NOT DEVICE RELATED. THE PATIENT WAS DOING WELL.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT IS EXPERIENCING PAIN IN HER THORACIC SPINE DESCRIBED AS A CONSTANT DULL ACHE WITH INTERMITTENT SHARP PAIN. THE PATIENT STATES THAT PROLONGED SITTING AND LAYING DOWN AGGRAVATES HER PAIN. THE PATIENT IS UNABLE TO IDENTIFY IF THE DEVICE IS PROVIDING SIGNIFICANT RELIEF OF HER PAIN. THE PHYSICIAN PLANS ON STARTING THE PATIENT ON IV ANTIBIOTICS THEN PERFORMING AN SI JOINT INJECTION. THEN FOR THE FOLLOW-UP VISIT THE PHYSICIAN WILL PERFORM A MEDIAL BRANCH BLOCK INJECTION.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT IS EXPERIENCING PAIN IN HER THORACIC SPINE DESCRIBED AS A CONSTANT DULL ACHE WITH INTERMITTENT SHARP PAIN. THE PATIENT STATES THAT PROLONGED SITTING AND LAYING DOWN AGGRAVATES HER PAIN. THE PATIENT IS UNABLE TO IDENTIFY IF THE DEVICE IS PROVIDING SIGNIFICANT RELIEF OF HER PAIN. THE PHYSICIAN PLANS ON STARTING THE PATIENT ON IV ANTIBIOTICS THEN PERFORMING AN SI JOINT INJECTION. THEN FOR THE FOLLOW-UP VISIT THE PHYSICIAN WILL PERFORM A MEDICAL BRANCH BLOCK INJECTION.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT IS EXPERIENCING PAIN IN HER THORACIC SPINE DESCRIBED AS A CONSTANT DULL ACHE WITH INTERMITTENT SHARP PAIN. THE PATIENT STATES THAT PROLONGED SITTING AND LAYING DOWN AGGRAVATES HER PAIN. THE PATIENT IS UNABLE TO IDENTIFY IF THE DEVICE IS PROVIDING SIGNIFICANT RELIEF OF HER PAIN. THE PHYSICIAN PLANS ON STARTING THE PATIENT ON IV ANTIBIOTICS THEN PERFORMING AN SI JOINT INJECTION. THEN FOR THE FOLLOW-UP VISIT THE PHYSICIAN WILL PERFORM A MEDIAL BRANCH BLOCK INJECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION SPINAL CORD STIMULAOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention