MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. EP-WORKMATE¿ CATHETER INTERFACE MODULE, CABLE, SCSI, 10'; PROGRAMMABLE DIAGNOSTIC COMPUTER

Model Number 100078213

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  

Manufacturer Narrative

Review of the images attached to the field service report indicated that some of the pins on the scsi cable connector had an anomaly.However, the scsi cable in question was not returned for evaluation.The reported complaint that the nurse received an electrical shock when the scsi cable was touched could not be conclusively determined.

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 consequences however the user received a burn at the location of the shock.

• Brand Name: EP-WORKMATE¿ CATHETER INTERFACE MODULE, CABLE, SCSI, 10'
• 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: elizabeth boltz ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 7796981
• MDR Text Key: 117582909
• Report Number: 2184149-2018-00129
• 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
• Report Date: 08/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 100078213
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: EP-WORKMATE¿ SCU
• Patient Outcome(s): Other