Model Number DB-1110C |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Intermittent Energy Output (4025)
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Patient Problems
Paralysis (1997); No Consequences Or Impact To Patient (2199)
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Event Date 02/07/2019 |
Event Type
Injury
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Manufacturer Narrative
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It is indicated that the device will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.A review of the device history records will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.
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Event Description
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A report was received that a couple weeks before attending the clinic, the patient was unable to move for about an hour.It was noted by the dbs programmer that the ipg had been off for a two hour period.The patient is scheduled to return for a follow up visit.
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Manufacturer Narrative
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Additional information was received that (b)(6), the dbs nurse who reported the event, reported that the patient's wife may have accidently switched the patient's battery off via the handheld remote control.A database analysis was performed and revealed that the ipg exhibits normal device characteristics and is performing as expected, with no anomalies.
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Event Description
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A report was received that a couple weeks before attending the clinic, the patient was unable to move for about an hour.It was noted by the dbs programmer that the ipg had been off for a two hour period.The patient is scheduled to return for a follow up visit.
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Search Alerts/Recalls
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