MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. SINGLE LESION ET20S¿ PAIN MANAGEMENT RF GENERATOR; ELECTROSURGICAL SPINE GENERATOR

Model Number	NT7209975
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/10/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in a subsequent submission. .
Event or Problem Description
During the procedure, a warning 2: high load impedance error message displayed and the procedure was cancelled.Multiple probes, adapters and grounding pads were attempted with no resolution.All connections were checked with no and no issues were found and the procedure was cancelled.There were no adverse consequences to the patient due to the cancellation.
Additional Manufacturer Narrative
One single lesion et20s¿ pain management rf generator was received for analysis.Ac power was applied to the returned rf generator which would not initialize and complete the boot sequence.Additional testing isolated the psu (power supply unit) as the root cause of the reported error message.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined the process was performed and completed in accordance with abbott specifications and procedures.Based on the information provided to abbott and the investigation performed, the root cause of the reported error message and subsequent procedure cancellation was isolated to abnormal functionality of the power supply unit.

• Brand Name: SINGLE LESION ET20S¿ PAIN MANAGEMENT RF GENERATOR
• Common Device Name: ELECTROSURGICAL SPINE GENERATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• MDR Report Key: 8658255
• Report Number: 2184149-2019-00100
• Device Sequence Number: 1889226
• Product Code: GEI
• UDI-Device Identifier: 05415067022325
• UDI-Public: 05415067022325
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K033981
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: NT7209975
• Device Lot Number: 6319717
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/10/2019
• Supplement Date Received by Manufacturer: 07/18/2019
• Initial Report FDA Received Date: 05/31/2019
• Supplement Report FDA Received Date: 07/19/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other