BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 2602988 · Received June 7, 2012

    Report

    Report Number
    3004209178-2012-04155
    Event Type
    Injury
    Date Received
    June 7, 2012
    Report Date
    May 11, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3998, LOT# V053142, IMPLANTED: 2007-(B)(6), EXPLANTED: 2012-(B)(6), PRODUCT TYPE LEAD PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: 2012-(B)(6), PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3998, LOT# V053142, IMPLANTED: 2007-(B)(6), PRODUCT TYP LEAD, PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: 2012-(B)(6), PRODUCT TYP LEAD. (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: (B)(4), LOT# V053142, SERIAL#, IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS SEEN THIS PAST MONDAY AND WAS DOING OKAY WITH HIS STIMULATION. THE PATIENT WAS STILL EXPERIENCING A SMALL AMOUNT OF ABDOMINAL PAIN BUT WAS RECEIVING GOOD STIMULATION. NO FURTHER INTERVENTIONS WERE SCHEDULED AT THAT TIME. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS SEEN BY THE PHYSICIAN THREE DAYS PRIOR TO REPORT. THE PATIENT HAD CONTINUED IMPROVEMENT. THE PATIENT DIDN'T REQUIRE HOSPITALIZATION DUE TO THE EVENT AND NO INJURY WAS NOTED AS PATIENT OUTCOME.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD A LEAD REVISION ON (B)(6)-2012. IT WAS STATED THAT THE LEAD WAS REPOSITIONED DUE TO STIMULATION IN WRONG LOCATION. THE REPORTER STATED THAT THE PATIENT EXPERIENCED STIMULATION IN HIS RIBS.

    Description of Event or Problem · 1

    IT WAS REPORTED WHEN STIMULATION WAS TURNED ON, THERE WAS LOSS OF THERAPEUTIC EFFECT. THERE WERE UNSPECIFIED LEAD ISSUES. THE PATIENT WAS NOT RECEIVING ANY STIM THERAPY, SO A REVISION WAS PLANNED TO ADDRESS THIS. PATIENT OUTCOME WAS NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION CLARIFIED THE PATIENT'S PRIOR LEAD WAS CHANGED TO A "565" SURGICAL LEAD ON (B)(6) 2012, BECAUSE THE COVERAGE WAS NOT "GOOD." FOLLOWING THAT REVISION THE PATIENT HAD THE ISSUES WITH THE LOSS OF THERAPEUTIC EFFECT, NO STIMULATION THERAPY, AND LEAD ISSUES WHICH WERE PREVIOUSLY REPORTED IN THE INITIAL REGULATORY REPORT. ABOUT 5 WEEKS AFTER THE LEAD REPLACEMENT, THE PATIENT HAD ANOTHER REVISION ON (B)(6) 2012. IT WAS UNKNOWN WHAT WAS DONE DURING THIS REVISION. FOLLOWING THE 2ND REVISION THE PATIENT HAD ANTERIOR STIMULATION IN THE TORSO AND ABDOMINAL CRAMPING. IT WAS NOTED THE LEAD WAS IN THE T8-9 AREA. THE PATIENT HAD NOT BEEN USING THE STIMULATION "VERY MUCH" DUE TO THE CRAMPING SYMPTOMS, BUT THE CRAMPING HAD BECOME LESS INTENSE. THE REPORTER STATED THE PATIENT WAS ENCOURAGED TO USE THE STIMULATION MORE IN THE NEXT 2 WEEKS, AND THEN THE PATIENT'S SYMPTOMS WERE GOING TO BE RE-EVALUATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT PUERTO RICO OPERATIONS CO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention