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SYNCHROMED II Adverse Event — Malfunction (MDR 2182207-2008-00759)

SYNCHROMED II Adverse Event — Malfunction (MDR 2182207-2008-00759) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: SYNCHROMED II; Manufacturer: MEDTRONIC NEUROMODULATION; Report number: 2182207-2008-00759.

DeviceSYNCHROMED II
ManufacturerMEDTRONIC NEUROMODULATION
Report number2182207-2008-00759
Event typeMalfunction
Product problemY
Date received2008-02-15
Report sourceHealth Professional
NarrativeTHE HCP REPORTED THAT THE PT HAD AN MRI AND HIS PUMP STALLED. TELEMETRY, AT THE TIME, SHOWED A STALL AT 11:18 AND IT HAD NOT YET RECOVERED AT 15:57; THE PT'S MRI WAS COMPLETED AT APPROX 13:30. NO PT SYMPTOMS WERE REPORTED. IN F/U, THE HCP REPORTED THAT HE THOUGHT THE STALL ONLY LASTED ABOUT 3 HRS, BUT TELEMETRY SHOWED THAT IT WAS LONGER THAN THAT AT THE TIME OF THE EVENT, SO IT IS UNCLEAR HOW LONG
SourceopenFDA MAUDE (device adverse events)

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