Model Number GALI DF4 SONR CRT-D 2841 |
Device Problem
Premature Discharge of Battery (1057)
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Patient Problems
Dyspnea (1816); Fatigue (1849)
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Event Date 10/21/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The device involved in this mdr report is not approved in the united states; however, it is similar to a device manufactured by microport crm that was cleared or approved by fda for marketing in the united states.
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Event Description
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Reportedly, (b)(6) 2022 the subject device was explanted due to premature depletion with absence of output (ecg revealed the device was not pacing).By trying to interrogate the device, no led was on.
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Event Description
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Reportedly, on (b)(6) 2022 the subject device was explanted due to premature depletion with absence of output (ecg revealed the device was not pacing).By trying to interrogate the device, no led was on.
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Manufacturer Narrative
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Please refer to the updated analysis report.
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Search Alerts/Recalls
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