BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 3203552 · Received July 3, 2013

    Report

    Report Number
    3004209178-2013-11221
    Event Type
    Injury
    Date Received
    July 3, 2013
    Report Date
    June 10, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 355031, LOT# N261750, IMPLANTED: (B)(6) 2010. PRODUCT TYPE: SCREENING DEVICE: PRODUCT ID 37743, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006. PRODUCT TYPE: RECHARGER: PRODUCT ID 3887-33, LOT# V519452, IMPLANTED: (B)(6) 2012. PRODUCT TYPE: LEAD: PRODUCT ID 3550-39, LOT# N334884, IMPLANTED: (B)(6) 2012. PRODUCT TYPE: ACCESSORY: PRODUCT ID 3887-33, LOT# J0314145V, IMPLANTED: (B)(6) 2003. PRODUCT TYPE: LEAD: PRODUCT ID 3708360, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006. PRODUCT TYPE: EXTENSION: PRODUCT ID 3708360, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006. PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS SCHEDULED FOR SURGERY IN TWO WEEKS. ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT¿S SURGERY WAS RESCHEDULED, BECAUSE OF THE PATIENT'S PULMONARY EMBOLISM LAST YEAR AND UNCONTROLLED INR (INTERNATIONAL NORMALIZED RATIO) {PLEASE REFER TO MFG. REPORT NO. 3004209178-2013-12727}.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) HAD BEEN TURNED OFF FOR THE ¿PAST FEW WEEKS¿ DUE TO A SHOCKING SENSATION. THE REPORTER STATED THE INS STATUS WAS ¿OK¿ AND IMPEDANCES GREATER THAN 10 ,000 OHMS WERE REPORTED ON A ¿MAJORITY OF CONTACTS.¿ IT WAS NOTED THE PATIENT HAD A SURGICAL REVISION OF THE LEADS PLANNED IN TWO WEEKS BUT THE DATE WAS UNKNOWN. IT WAS FURTHER NOTED THE LEAD REVISION WAS DUE TO A SHOCKING OR JOLTING SENSATION THAT OCCURRED FOLLOWING A FALL. THE REPORTER STATED THE PATIENT HAD A HISTORY OF FALLING. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306262 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 00057 YR Required Intervention