Based on the information available to date, the reported left scapular abscess appears to be the result of lead dissolution: when a lead fracture occurs and a small length of the lead is exposed to extracellular fluid, the broken end of the lead acts as the electrode.The current delivered by the pulse generator is conducted through the very small surface area of the fractured lead.The result of this event is the pitting at the broken end of the coil wire.Adverse events associated with this event can include infection-like symptoms including inflammation, pain, or edema of abscess.The adverse events reported here appear to be the result of the lead malfunction reported in mfr report #1644487-2014-02711.
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Brand name, corrected data: previously submitted mdr indicated that the suspect medical device was the generator; however, this is actually the lead.Type of device, corrected data: previously submitted mdr indicated that the suspect medical device was the generator; however, this is actually the lead.Model #, serial #, lot #, expiration date, corrected data: previously submitted mdr indicated that the suspect medical device was the generator; however, this is actually the lead.Device manufacture date, corrected data: previously submitted mdr indicated that the suspect medical device was the generator; however, this is actually the lead.
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