BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIT IMPLANTABLE SLIM TIP LEAD, 50CM

    MDR report key: 13624733 · Received February 28, 2022

    Report

    Report Number
    1627487-2022-01137
    Event Type
    Injury
    Date Received
    February 28, 2022
    Date of Event
    February 10, 2022
    Report Date
    August 8, 2022
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    PMP
    PMA / PMN Number
    P150004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS ESTIMATED.

    Additional Manufacturer Narrative · 0

    MANUFACTURING INVESTIGATION: DHR REVIEW: REVIEW DHR, ASSOCIATED NCMR / REWORKS, AND DOCUMENT CONCLUSION. DEVICE HISTORY RECORD (DHR) FOR WORK ORDER # 52933871, SERIAL # (B)(6), PART # 100155674, BATCH# 6306886, AND MODEL MN20450-50A WAS REVIEWED. THERE WERE NO ANOMALIES FOUND THAT WOULD BE RELATED TO THE ALLEGATION. ACCORDING TO THE DHR, THIS WORK ORDER WAS COMPRISED OF TWO BATCHES (6247978 AND 6248120) OF THE LEAD, 50CM SLIM TIP WITH MARKER, PART # AD1671. ACCORDING TO THE RECEIVING INSPECTION RECORDS FOR BATCHES 6247978 AND 6248120 OF THE LEADS MEET ALL CUSTOMER DRAWING SPECIFICATIONS PER AD1671. RECEIVING INSPECTIONS PERFORMED AQL SAMPLING AND BATCH WAS ACCEPTED PER SPECIFICATIONS. AS THESE UNITS ARE SENT TO AN OUTSIDE VENDOR TO APPLY THE MARKER, THOSE TWO BATCHES ARE TRACED THROUGH OUR ENTERPRISE RESOURCE PLANNING SOFTWARE TO TWO BATCHES (6171197 AND 6185950) OF THE LEAD ASSY., SLIM TIP, 50CM, PART # AD1667 THAT WERE BUILT ON WORK ORDERS 52772968 AND 52791243. ACCORDING TO THE DHR¿S PART # AD1667 HAD BEEN MANUFACTURED AND TESTED ACCORDING TO CURRENT MANUFACTURING SPECIFICATIONS. UNITS OF BATCHES # 6171197 AND 6185950 OF PART # AD1667 THAT WERE RELEASED INTO COMPONENT GOODS PASSED ALL MANUFACTURING VISUAL INSPECTION AND ELECTRICAL TESTING REQUIREMENTS. REVIEW CONCLUSION: ALLEGATION WAS UNABLE TO BE CONFIRMED OR NOT CONFIRMED (UNABLE TO DETERMINE FROM INFORMATION AVAILABLE. RATIONALE: DHR REVIEW HAS DETERMINED THAT MANUFACTURING COMPLETED ALL STEPS CORRECTLY AND THERE WERE NO ERRORS IN THE PRODUCTION OF THE PRODUCT. PRIOR TO RELEASE, ALL RELEASED UNITS WERE CONFORMING TO ALL APPLICABLE ACCEPTANCE CRITERIA FOR EACH LEVEL BUILD. BASED ON THE INVESTIGATION PERFORMED, THERE IS NO INDICATION THERE IS AN ESCAPE FROM MANUFACTURING AND THEREFORE THE COMPLAINT CANNOT BE CONFIRMED TO BE A PLANO NEUROMODULATION MANUFACTURING RELATED EVENT. UNIT NOT BEING RETURNED.

    Description of Event or Problem · 0

    RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2022-01136. IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION WITH THEIR DRG SYSTEM. DIAGNOSTICS REVEALED HIGH IMPEDNACES ON ONE LEAD. IMAGING REVEALED THAT THE OTHER LEAD HAD MIGRATED OUT TO THE EPIDURAL SPACE FROM THE DRG PLACEMENT. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN BOTH LEADS WERE EXPLANTED AND REPLACED. POST-OPERATIVELY, STIMULATION THERAPY WAS RESTORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1298198 KIT IMPLANTABLE SLIM TIP LEAD, 50CM DRG SLIM TIP LEAD PMP ABBOTT MEDICAL MN20450-50A 6306886

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other