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SYNCHROMED II Adverse Event — Injury (MDR 3004209178-2008-00726)

SYNCHROMED II Adverse Event — Injury (MDR 3004209178-2008-00726) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: SYNCHROMED II; Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO.; Report number: 3004209178-2008-00726.

DeviceSYNCHROMED II
ManufacturerMEDTRONIC PUERTO RICO OPERATIONS CO.
Report number3004209178-2008-00726
Event typeInjury
Product problemN
Date received2008-02-15
Report sourceConsumer, Health Professional
NarrativeTHE PATIENT INITIALLY REPORTED EXPERIENCING PRURITUS OVER HER ENTIRE BODY. FOLLOW UP WITH THE HCP INDICATED THE PRURITUS WAS CAUSED BY THE MORPHINE SULFATE INTRATHECAL TRIAL THAT HAD BEEN PREVIOUSLY PERFORMED. ADDITIONALLY, THE HCP REPORTED THE PATIENT DEVELOPED A HEMATOMA FOLLOWING IMPLANT OF THE INTRATHECAL DRUG DELIVERY PUMP. THE PUMP WAS PLACED IN 2007, DUE TO SEVERE BACK PAIN FOR WHICH THE PA
SourceopenFDA MAUDE (device adverse events)

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