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	Failure to Deliver Energy (1211)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results, method and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
During a procedure, while performing sensory motor testing a red light displayed and the generator no longer functioned as intended.The procedure was cancelled.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
One single lesion et20s¿ pain management rf generator was received into the lab for analysis.Visual inspection of the returned product confirmed all input and output connectors are free of physical damage and all labeling is legible and correctly oriented.Ac power was applied to the et20s which briefly displayed the software version of 2.00 prior to the successful execution of the power on self-test.Default values were then displayed in a numerical format that is consistent with this software version.Stimulate sensory, motor, pulse and lesion modes were each evaluated.Functional testing confirmed normal impedance and temperature values during the application of rf energy.No warnings, error messages, impedance or temperature fluctuations were observed during the evaluation performed.Target temperatures were monitored and achieved during the application of rf energy.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 field reported event cannot be conclusively determined as the reported issue was unable to be reproduced.The returned product operated as designed during the evaluation period.

• 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: 9309299
• Report Number: 2184149-2019-00224
• Device Sequence Number: 18947512
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2020

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 Catalogue Number: NT7209975
• Device Lot Number: 6353480
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/30/2019
• Supplement Date Received by Manufacturer: 01/15/2020
• Initial Report FDA Received Date: 11/12/2019
• Supplement Report FDA Received Date: 01/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other