The pacemaker was received for analysis.Prior to the analysis of the device, the quality documents accompanying the manufacturing process for this pacemaker were reinvestigated.All production steps had been performed accordingly.Particularly the final acceptance test proved the device functions to be as specified.The pacemaker was implanted for 101 months.Upon receipt, the clinical observation was confirmed, the device interrogation revealed the battery status eri.Based on the inspection of the pacemakers memory content the eri status was triggered on (b)(6) 2016 most likely as a result of the reported radiotherapy.However, the amount of charge taken from the battery was verified.The battery condition was found to be as expected.The ability of the device to deliver therapies was verified.The anti-bradycardia pacing pulses proved to be normal and in amplitude and frequency as programmed.There was no indication of a device malfunction.In conclusion, the battery status eri resulted most likely from the reported radiotherapy.During analysis the pacemaker was fully functional.
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