Model Number 3660 |
Device Problems
Wireless Communication Problem (3283); Application Program Freezes, Becomes Nonfunctional (4031)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Date 08/06/2019 |
Event Type
Injury
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Manufacturer Narrative
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The device is included in the neuromodulation implantable pulse generator (ipg) inoperable when exposed to monopolar electrosurgery advisory notice issued by abbott on 02 june 2017.
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Event Description
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It was reported that following a surgical procedure in which the system was not placed into surgery mode as recommended, the ipg could no longer communicate with external devices.In turn, the patient may undergo surgical intervention to address the issue sometime in the future.
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Manufacturer Narrative
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During processing of this complaint, attempts were made to obtain complete event information.H6 - method code: 4117 was updated to 4114.
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Event Description
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Additional information was received that surgical intervention occurred during which the ipg was explanted and replaced to address the issue.
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Search Alerts/Recalls
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