Model Number 6660 |
Device Problem
Wireless Communication Problem (3283)
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Patient Problems
Failure of Implant (1924); Movement Disorder (4412)
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Event Date 01/24/2024 |
Event Type
Injury
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Manufacturer Narrative
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Date of event is estimated.Initial reporter phone number: (b)(6).Based on information obtained the device is included in the neuromodulation implantable pulse generator (ipg) unable to exit mri mode advisory notice issued by abbott on 22 june 2023.
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Event Description
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It was reported that the patient's ipg became inoperable after an mri where the ipg was set to mri mode.Troubleshooting was unable to resolve the issue.
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Event Description
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Additional information received indicates that the patient underwent surgical intervention during which the ipg was explanted and replaced with no complications.
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Event Description
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Additional information received indicates that the patient may undergo surgical intervention to address the issue.
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Manufacturer Narrative
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The report of inoperable ipg was confirmed.The inability to communicate between the clinicians programmer and the implantable pulse generator was due to the device entering the service application state.The service application condition occurred on (b)(6) 2024 the day of the mri procedure.As received, the device was in mri mode.Once the device was moved into therapy app stated it was able to be moved out of mri mode without any issues.Mri settings were not provided by the field.
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Search Alerts/Recalls
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