BOSTON SCIENTIFIC CORPORATION VALITUDE CRT-P PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)
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Model Number U125 |
Device Problem
Device Displays Incorrect Message (2591)
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Patient Problem
No Patient Involvement (2645)
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Event Date 02/25/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Upon receipt at our post market quality assurance laboratory, it was noted that the device was returned in the original sterile packaging.
An evaluation of the device was performed.
Review of the device memory confirmed that a low voltage alert, code 1003, was recorded and that the device recorded low temperature readings prior to setting the low voltage alert.
If this model device is stored in environments where temperatures can drop below the recommended storage temperature, battery voltage readings that are low enough to set a low voltage alert may result.
This appears to be the case with this device.
The battery did recover after the device was removed from the cold.
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Event Description
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It was reported to boston scientific that a low voltage alert, code 1003, was recorded on this pacemaker pre-implant.
If this model device is stored in environments where temperatures can drop below the recommended storage temperature, battery voltage readings that are low enough to set a low voltage alert may result.
This appears to be the case with this device.
No adverse patient effects were reported.
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