MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. ENSITE VELOCITY¿ ARRAYLINK MODULE; PROGRAMMABLE DIAGNOSTIC COMPUTER

Model Number	H421070
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/29/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
During the procedure, a data module error was received when validating the catheter.The catheter was replaced but the issue remained.The procedure was cancelled and there were no adverse consequences to the patient.
Additional Manufacturer Narrative
One array link module was received for evaluation.Visual inspection revealed the connectors and labels appeared to have no physical damage.The mounting hardware was secured.Normal wear and tear was observed on the exterior enclosure.No other visible anomalies were observed.The alden cable test and eeprom test ran with no errors.No issue was found with the module.Based on the information provided to abbott and the investigation performed, the reported event was unable to be confirmed.The returned product functioned properly during the evaluation.No hardware abnormalities that would have resulted in the reported error message were identified.

• Brand Name: ENSITE VELOCITY¿ ARRAYLINK MODULE
• Common Device Name: PROGRAMMABLE DIAGNOSTIC COMPUTER
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• MDR Report Key: 7644502
• Report Number: 2184149-2018-00083
• Device Sequence Number: 152374
• Product Code: DQK
• UDI-Device Identifier: 05414734210706
• UDI-Public: 05414734210706
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K160187
• 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): 07/18/2018

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: H421070
• Device Lot Number: 623240001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/29/2018
• Supplement Date Received by Manufacturer: 07/16/2018
• Initial Report FDA Received Date: 06/27/2018
• Supplement Report FDA Received Date: 07/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARRAYLINK CATHETER; ARRAYLINK CATHETER
• Outcome Attributed to Adverse Event: Other