Model Number SC-1132 |
Device Problems
Premature Discharge of Battery (1057); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Nerve Damage (1979); Neuropathy (1983); Pain (1994); No Code Available (3191)
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Event Date 10/19/2020 |
Event Type
Injury
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Manufacturer Narrative
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Approximated based on the date the manufacturer became aware of the event.
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Event Description
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It was reported that the patient was having pain at the ipg site due to excessive weight loss from a non device related surgery.The physician believed that the pain was due to the placement of the ipg.The patient was also suffering from nerve damage and neuropathy.
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Event Description
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It was reported that the patient was having pain at the ipg site due to excessive weight loss from a non device related surgery.The physician believed that the pain was due to the placement of the ipg.The patient was also suffering from nerve damage and neuropathy.The patient was looking forward for an explant.Additional information was received that the patients ipg was non functional.The patient underwent an ipg replacement procedure wherein an mri compatible ipg was implanted and was doing well.Explanted ipg will not be returned.
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Search Alerts/Recalls
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