BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 2983495 · Received February 28, 2013

    Report

    Report Number
    3004209178-2013-03174
    Event Type
    Injury
    Date Received
    February 28, 2013
    Report Date
    February 7, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 39565-30 LOT# SERIAL# (B)(4), IMPLANTED: 2009 (B)(6), EXPLANTED: 2013 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 37743 LOT# SERIAL# (B)(4), IMPLANTED: 2009 (B)(6), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID, 3708140 LOT# SERIAL# (B)(4), IMPLANTED: 2009 (B)(6), EXPLANTED: 2013 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID, 3708140 LOT# SERIAL# (B)(4), IMPLANTED: 2009 (B)(6), EXPLANTED: 2013 (B)(6), PRODUCT TYPE EXTENSION. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    FINAL DEVICE ANALYSIS FOR STIMULATOR NKL709331H REVEALED NO ANOMALY. FINAL DEVICE ANALYSIS FOR EXTENSION NJB047863V REVEALED NO ANOMALY. FINAL DEVICE ANALYSIS FOR EXTENSION NJB048404V REVEALED NO ANOMALY. FINAL DEVICE ANALYSIS FOR LEAD N177903002 REVEALED NO SIGNIFICANT ANOMALY.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD THEIR DEVICE REMOVED. THE PATIENT HAD LOST A SIGNIFICANT AMOUNT OF WEIGHT AND THE IMPLANTABLE NEUROSTIMULATOR (INS) SITE BECAME UNCOMFORTABLE AND RED. THE PATIENT RECOVERED WITHOUT SEQUELA AND THE DEVICE WAS NOT REPLACED. NO FURTHER INFORMATION HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86372 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention