Model Number PULSAR |
Device Problems
Improper or Incorrect Procedure or Method (2017); Device Operates Differently Than Expected (2913)
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Patient Problems
Head Injury (1879); Failure of Implant (1924)
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Event Date 06/20/2015 |
Event Type
Injury
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Manufacturer Narrative
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The device has been explanted and should be returned to the manufacturer for evaluation.When available, a device failure analysis will be submitted as a follow up report.
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Event Description
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It was reported that the patient suffered an impact to the head that caused damage to the device.Thereafter, the patient has been re-implanted.
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Manufacturer Narrative
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Additional information: based on the received information, the implant housing was damaged due to an accident.The device has not been received for investigation.The complaint can be re-opened when the device is available for investigation.
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Event Description
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It was reported that the patient suffered an impact to the head that caused damage to the device.The patient has been re-implanted.
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Manufacturer Narrative
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The device investigation revealed mechanical damage to the stimulator housing that is typical for severe external impact to the housing.The problems described in the recipient report appear to match the damage found.This is a final report.
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Event Description
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It was reported that the recipient had an impact to the head that caused damage to the device.The recipient underwent re-implantation surgery on (b)(6) 2015.
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Search Alerts/Recalls
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