Model Number 394919 |
Device Problem
Premature Elective Replacement Indicator (1483)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/10/2019 |
Event Type
malfunction
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Event Description
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This device was explanted and replaced due to eri from lv lead with high thresholds and is programmed to 6.
5v at 1.
0ms.
No adverse patient events were reported.
Should additional information become available, this file will be updated.
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Manufacturer Narrative
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We received your event description for the above mentioned device and would like to thank you for supporting our post-market surveillance.
As of today, the medical device is not available for analysis, therefore the device itself could not be investigated.
The information you provided has been entered into our quality system as a complaint.
These types of complaints are used to evaluate systems and device performance throughout our organization and help to maintain and improve the performance of our devices.
Should additional relevant information or the device itself become available, the investigation will be updated.
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Manufacturer Narrative
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The pacemaker was returned and analyzed.
The memory content demonstrated a normal functionality of the device while implanted and in service.
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.
The device interrogation revealed the battery status - ok - with 20 percent remaining battery capacity.
The archive data and the programmed parameters were inspected.
High left ventricular pacing outputs of 6.
5v and 1.
0ms were documented in the archive data.
This represents a high current program, which results in a faster discharge of the battery.
The amount of charge taken from the battery was verified and the battery condition was found to be as expected.
In conclusion, the pacemaker was fully functional.
The battery condition was anticipated.
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Search Alerts/Recalls
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