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PROCLAIM DRG IMPLANTABLE PULSE GENERATOR Adverse Event — Injury (MDR 1627487-2020-04124)

PROCLAIM DRG IMPLANTABLE PULSE GENERATOR Adverse Event — Injury (MDR 1627487-2020-04124) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: PROCLAIM DRG IMPLANTABLE PULSE GENERATOR; Generic name: DRG IPG; Manufacturer: ST. JUDE MEDICAL - NEUROMODULATION.

DevicePROCLAIM DRG IMPLANTABLE PULSE GENERATOR
Generic nameDRG IPG
ManufacturerST. JUDE MEDICAL - NEUROMODULATION
Report number1627487-2020-04124
Event typeInjury
Product problemN
Date received2020-04-28
Report sourceCOMPANY REPRESENTATIVE, FOREIG
NarrativeIT WAS REPORTED THE PATIENT EXPERIENCED PAIN AT THE DRG IPG POCKET SITE. REPORTEDLY, IF THE PATIENT TURNED THE GENERATOR OFF THE PAIN WOULD STOP. CONSEQUENTLY, SURGICAL INTERVENTION WAS TAKEN AND THE GENERATOR WAS MOVED TO ANOTHER POCKET SITE. THE SURGICAL INTERVENTION ADDRESSED THE POCKET PAIN AND THE PATIENT WAS REPORTEDLY DOING WELL POSTOPERATIVELY.
SourceopenFDA MAUDE (device adverse events)

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