MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. ENSITE PRECISION LINK SENSOR ENABLED; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number	H702475
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One ensite¿ precision¿ link sensor enabled was received for evaluation.Visual inspection of the connectors and chassis revealed no physical damage.A small nick was observed at the front panel.The precision link was powered on and audible beeps were observed indicating a successful boot up.The field reported event was confirmed as communication could not be established.Internal inspection verified all mounting hardware were secured and a thermal scent was observed.Inspection at the system controller unit (scu) board verified a thermal event occurred at integrated chip lm317.The root cause was isolated to the scu board.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information provided to abbott and the investigation performed, the root cause was isolated to a thermal event on the system controller unit board.
Event or Problem Description
This report is being submitted based on analysis which revealed a thermal event occurred.

• Brand Name: ENSITE PRECISION LINK SENSOR ENABLED
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• MDR Report Key: 12416144
• Report Number: 2184149-2021-00266
• Device Sequence Number: 3577215
• Product Code: DQK
• UDI-Device Identifier: 05415067024756
• UDI-Public: 05415067024756
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K183128
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/02/2021

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
• Operator of Device: Health Professional
• Device Model Number: H702475
• Device Catalogue Number: H702475
• Device Lot Number: 6568470
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2021
• Initial Report FDA Received Date: 09/02/2021
• Patient Sequence Number: 1