Model Number PLATINIUM VR 1240 |
Device Problem
Wireless Communication Problem (3283)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 04/27/2018 |
Event Type
malfunction
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Event Description
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When the device was interrogated in rf telemetry, a message appeared saying that the interrogation failed and asking to quit the session to re-interrogate the device.After several attempts, interrogations in rf telemetry were unsuccessful, but regular communication was observed with the cpr3 head.Another device was successfully interrogated in rf, therefore the subject device is incriminated.
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Manufacturer Narrative
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Preliminary analysis confirmed the reported issue due to a manufacturing issue.
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Event Description
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When the device was interrogated in rf telemetry, a message appeared saying that the interrogation failed and asking to quit the session to re-interrogate the device.After several attempts, interrogations in rf telemetry were unsuccessful, but regular communication was observed with the cpr3 head.Another device was succesfully interrogated in rf, therefore the subject device is incriminated and was not implanted.
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Event Description
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When the device was interrogated in rf telemetry, a message appeared saying that the interrogation failed and asking to quit the session to re-interrogate the device.After several attempts, interrogations in rf telemetry were unsuccessful, but regular communication was observed with the cpr3 head.Another device was successfully interrogated in rf, therefore the subject device is incriminated and was not implanted.
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Manufacturer Narrative
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Please refer to the attached investigation report.
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Search Alerts/Recalls
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