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

Model Number NT7209975

Device Problem Unexpected Shutdown (4019)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/02/2022

Event Type  malfunction  

Manufacturer Narrative

During processing of this incident, attempts were made to obtain complete patient information.

Event Description

During the procedure, the generator would shut off and restart on its own.It would restart with each level, however after the 4th level, the generator did not work.The last level of the procedure could not be completed as a result, but there was no adverse consequence to the patient.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: SINGLE LESION ET20S¿ PAIN MANAGEMENT RF GENERATOR
• Type of Device: ELECTROSURGICAL SPINE GENERATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC. (AF-ST. PAUL); one st. jude medical drive; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL, INC. (AF-ST. PAUL); one st. jude medical drive; st. paul MN 55117
• Manufacturer Contact: ronnie shalev ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 15536127
• MDR Text Key: 304714041
• Report Number: 2184149-2022-00243
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 05415067022325
• UDI-Public: 05415067022325
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K033981
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NT7209975
• Device Catalogue Number: NT7209975
• Device Lot Number: 6330596
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/08/2022
• Initial Date FDA Received: 10/04/2022
• Supplement Dates Manufacturer Received: 12/14/2022
• Supplement Dates FDA Received: 12/28/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/28/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1