MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. EP-WORKMATE¿ AND WORKMATE¿ CLARIS¿ EP-4¿ TOUCHSCREEN COMPUTER; GENERATOR, PULSE, PACEMAKER, EXTERNAL PROGRAMMABLE

Model Number	H21911
Medical Device Problem Code	Pacing Problem (1439)
Health Effect - Clinical Code	Ventricular Fibrillation (2130)
Date of Event	03/12/2019
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
Related manufacturing ref: 2184149-2019-00040.Near the end of a premature ventricular contraction (pvc) procedure, the touchscreen computer delivered six stimuli to the patient instead of three and induced ventricular fibrillation.The patient went into ventricular fibrillation and cardioversion was required to stabilize the patient.The procedure was completed successfully and the patient is in stable condition.
Additional Manufacturer Narrative
Additional information: one ep-workmate¿ and workmate¿ claris¿ ep-4¿ touchscreen computer was received for analysis.The pacing protocol being used during the field reported event was not communicated and remains undetermined.Multiple protocols may be programmed to provide extra beats which include incremental and decremental pacing options.Functional testing of the returned touchscreen confirmed stimulus outputs match the programmed settings in both preset and user defined protocols.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 received, the cause of the reported stimulation issue and subsequent ventricular fibrillation could not be conclusively determined.

• Brand Name: EP-WORKMATE¿ AND WORKMATE¿ CLARIS¿ EP-4¿ TOUCHSCREEN COMPUTER
• Common Device Name: GENERATOR, PULSE, PACEMAKER, EXTERNAL PROGRAMMABLE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• MDR Report Key: 8487017
• Report Number: 2184149-2019-00039
• Device Sequence Number: 14067850
• Product Code: JOQ
• UDI-Device Identifier: 05414734219112
• UDI-Public: 05414734219112
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K092913
• 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): 05/17/2019

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: H21911
• Device Catalogue Number: H21911
• Device Lot Number: 6101386
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/12/2019
• Supplement Date Received by Manufacturer: 05/16/2019
• Initial Report FDA Received Date: 04/05/2019
• Supplement Report FDA Received Date: 05/17/2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: WORKMATE¿ CLARIS¿ EP-4¿ CARDIAC STIMULATOR; WORKMATE¿ CLARIS¿ EP-4¿ CARDIAC STIMULATOR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Weight: 75