BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA 3 MM LEAD, 60 CM

    MDR report key: 2329100 · Received November 7, 2011

    Report

    Report Number
    1627487-2011-05390
    Event Type
    Injury
    Date Received
    November 7, 2011
    Date of Event
    October 4, 2011
    Report Date
    October 4, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: THE PRODUCT WAS RECEIVED INCOMPLETE. THE PADDLE LEAD WAS CUT INTO THREE PIECES (CONSISTENT WITH EXPLANT DAMAGE). MICROSCOPIC INSPECTION OF THE LEAD SEGMENT REVEALED BURN DAMAGE IN SEVERAL LOCATIONS CONSISTENT WITH AN ELECTROCAUTERY INSTRUMENT. THE PADDLE AND STIMULATION ELECTRODE MATRIX WERE IN GOOD CONDITION. THE TERMINAL ENDS WERE ALSO IN GOOD CONDITION. NO ANOMALIES WERE OBSERVED. THE LEAD WAS INCOMPLETE; THEREFORE, FUNCTIONAL TESTING WAS NOT PERFORMED. SJM HAS LIMITED INFO RELATED TO THE PT¿S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT¿S HISTORY TO THE EVENT REPORTED. SJM DIFFERS TO THE PT¿S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 1 OF 2. REFERENCE MFR REPORT#: 1627487-2011-05391. THE PT RECEIVED HER SCS SYSTEM ON (B)(6) 2011, INCLUDING AN IPG AND A PADDLE LEAD. IT WAS REPORTED THE PT WAS NOT RECEIVING ENOUGH PAIN RELIEF. AS A RESULT, THE PT'S IPG AND PADDLE LEAD WERE EXPLANTED. DURING THE SURGICAL PROCEDURE, THE DR NOTICED NUMEROUS EXPOSURES OF THE LEAD, AS WELL AS KINKING OF THE LEAD TAIL. THE DR WAS UNSURE IF THE LEAD'S INSULATION WAS BURNED DUE TO THE EXPLANT PROCEDURE. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENTA 3 MM LEAD, 60 CM SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3228 3252464

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention IMPLANTED:| SCS LEADS: MODELS 3066 (4)| IMPLANTED:| SCS LEAD EXTENSIONS: MODEL 3346 (2)