Model Number 302-30 |
Device Problems
Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Pain (1994)
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Event Date 04/10/2017 |
Event Type
malfunction
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Event Description
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It was reported that a patient was experiencing painful stimulation when the settings are increased.The physician suspected a lead fracture and planned to refer the patient for a full revision surgery as the generator was at near end of service.It was noted from a previous office visit in 2017 that in 2007, the patient had a fall that resulted in pain in the left chest area, which led to the physician turning off the patient's device.The device was turned back on in 2017 to settings that the patient could tolerate.Systems and normal diagnostics were performed, indicating no device malfunction or anomalies.The physician still suspected a lead fracture, though it was unclear why.No surgery has occurred to date.No further relevant information has been received to date.
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Manufacturer Narrative
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Corrected data: initial report inadvertently did not include diagnostic data from 2007.
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Event Description
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Follow-up with the physician indicated that painful stimulation was occurring in the left chest area when the magnet is swiped.It was asked why the lead fracture was suspected and if the fracture was suspected due to an observed impedance issue, and it was stated that the lead fracture was suspected due to the painful stimulation.No surgery has occurred to date.No further relevant information has been received to date.
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Event Description
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It was reported that the patient was had been in and out of the hospital with increased seizures, and in 2018 it was reported that the patient may have had a lead fracture.No known relevant surgical intervention has occurred to date.No further relevant information has been received to date.
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Search Alerts/Recalls
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