BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 3972922 · Received August 1, 2014

    Report

    Report Number
    3004209178-2014-13807
    Event Type
    Injury
    Date Received
    August 1, 2014
    Report Date
    July 9, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3550-39, LOT# N295554, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 37744, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3550-29, LOT# N243113, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 3776-75, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID: 3708120, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD BEEN HAVING A PROBLEM SINCE THE THURSDAY PRIOR TO THE REPORT WITH A POSSIBLE PINCHED NERVE AND THE PATIENT NEEDED AN MRI. THE PATIENT THOUGHT THAT THE DEVICE AND THE PAIN WERE ALL KIND OF RELATED. THE PATIENT HAD PAIN IN THEIR NECK AND ARMS AND THEY THOUGHT IT WAS BECAUSE OF A COMPRESSED NERVE. THEY HAD SHOOTING PAIN DOWN THEIR ARMS AND JOLTS WHEN THEY WOULD TURN THEIR NECK A CERTAIN WAY OR UP THEIR SPINE. THE PATIENT STARTED OUT WITH BURSITIS AND THEY WEREN¿T SURE IF IT WAS COMING FROM THEIR NECK OR SHOULDER. THE PATIENT ALSO HAD 2 DISCS COLLAPSE 3 YEARS PRIOR TO THE REPORT. IT WAS FURTHER REPORTED THAT THE PATIENT HAD A 50% OR GREATER REDUCTION IN SYMPTOMS. THE CAUSE OF THE EVENT WAS NOT DETERMINED BUT IT WAS DEVICE RELATED. IT WAS UNKNOWN IF REPROGRAMMING WAS NEEDED. THERE WAS NO DEATH. THE PATIENT RECOVERED WITH PERMANENT IMPAIRMENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INFORMATION REPORTED FROM THE DOCTOR REGARDING THE PATIENT RECOVERING WITH PERMANENT IMPAIRMENT WAS AN ERROR. THERE WAS NO DEATH AND NO PROBLEMS WITH THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450548 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 Other