MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. EP-WORKMATE¿ SCU-SIGNAL CONDITIONING UNIT (AMPLIFIER), 56 CHANNEL; PROGRAMMABLE DIAGNOSTIC COMPUTER

Model Number 09-1462-0056

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Electric Shock (2554); Partial thickness (Second Degree) Burn (2694)

Event Date 05/07/2018

Event Type  Injury  

Event Description

During an atrioventricular node ablation procedure a user shock occurred.During the procedure the signal from the ablation catheter was lost.The catheter, cabling and pins locations were changed but the issue was not resolved.It was suggested to change the scsi connector and when the nurse touched the connector she received an electric shock.The procedure was stopped due to this issue.There were no adverse patient or user consequences.

Manufacturer Narrative

The user received a burn at the location of the shock.One ep-workmate scu (signal conditioning unit) was received for evaluation.Continuity testing of pins 35 and 36 showed no shorts.Using a test standard scsi cable, a basic signal acquisition/quality test which included the baseline, amplitude, and switching were performed and confirmed that the returned amplifier performed within the factory specifications.An scu safety test was run and the unit passed.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.The reported complaint that the nurse received an electrical shock when the scsi cable was touched could not be reproduced during the evaluation.

• Brand Name: EP-WORKMATE¿ SCU-SIGNAL CONDITIONING UNIT (AMPLIFIER), 56 CHANNEL
• Type of Device: PROGRAMMABLE DIAGNOSTIC COMPUTER
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 7566180
• MDR Text Key: 109963408
• Report Number: 2184149-2018-00068
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K132073
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 09-1462-0056
• Other Device ID Number: 05415067003126
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/27/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/29/2010
• 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
• Patient Outcome(s): Other