DIGITRAK XT HOLTER RECORDER

Additional Manufacturer Narrative

FURTHER INVESTIGATION OF THIS ISSUE WAS NOT ABLE TO BE PERFORMED, AS NO FURTHER INFORMATION WAS AVAILABLE. INSUFFICIENT INFORMATION WAS PROVIDED TO CONTACT THE USER. BASED ON THE INFORMATION AVAILABLE, THE CAUSE OF THE REPORTED PROBLEM WAS NOT ABLE TO BE DETERMINED. THE REPORTED PROBLEM WAS NOT CONFIRMED. BASED ON THE INFORMATION AVAILABLE AND RESULTS OF ADDITIONAL ANALYSIS, NO FURTHER ACTION IS NECESSARY AT THIS TIME. WE ARE UNABLE TO CONFIRM THE FINAL DISPOSITION OF THE DEVICE BECAUSE THE CUSTOMER DID NOT PROVIDE FURTHER INFORMATION ON THIS ISSUE THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED.

Description of Event or Problem

IT WAS REPORTED THE PATIENT DEVELOPED BURNS ON THE SKIN AFTER USING THE DEVICE. THE PATIENT USED THE PHILIPS HOLTER MONITOR FOR TWO WEEKS. AFTER USE, THE PATIENT NOTED BURNS ON THE SKIN, WHICH BEGAN AS STINGING SENSATION AND AFTER REMOVAL OF THE MONITOR, THE DAMAGE TO THE SKIN WAS NOTED. IT WAS INDICATED THE PATIENT HAD A SCAR ON THEIR CHEST RELATED TO THE BURNS. THE RECEIVED MEDWATCH REPORT INDICATED THE REPORTED BURN REQUIRED INTERVENTION, WITH THE TREATMENT BEING LISTED AS ATENOLOL.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WAS FOUND WHICH INDICATES A DIFFERENT PRODUCT WAS INVOLVED (ELECTRODE - PATCH - UNIVERSAL 2 CHANNEL DEVICE), AND HAD ALREADY BEEN ADDRESSED IN A DIFFERENT COMPLAINT HANDLED BY PHILIPS AMBULATORY MONITORING AND DIAGNOSTICS (AM&D). AM&D DID NOT REPORT THIS TO THE FDA SINCE THEY WERE ABLE TO CONFIRM THAT THE PATIENT DID NOT GO TO THE EMERGENCY ROOM, URGENT CARE OR RECEIVE A WRITTEN PRESCRIPTION FROM THE PHYSICIAN.