Model Number MC1VR01 |
Device Problems
Premature Discharge of Battery (1057); Battery Problem (2885)
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Patient Problem
No Patient Involvement (2645)
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Event Date 03/23/2017 |
Event Type
malfunction
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Manufacturer Narrative
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A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that the leadless implantable pulse generator (ipg) device was selected ten days before the procedure, yet exhibited premature battery depletion prior to implant.There was indication of low battery voltage from possible low temperature damage.The device was not used and was replaced.There was no patient involvement.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Product event summary: the device was returned and analyzed.The returned device indicated that the battery voltage was below implant specification.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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