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

Model Number	H702475
Medical Device Problem Codes	Thermal Decomposition of Device (1071); Device Emits Odor (1425)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
Event or Problem Description
During the procedure, the precision link smelled of burning and displayed arcing when powered on.An arced/blackened spot is visible on one of the spots where the 4 pin prong is inserted for power.The cover was taken off the link and no internal damage was noted other than the power connection.There were no adverse consequences to the patient or the user.
Event or Problem Description
This was a supraventricular tachycardia procedure.
Additional Manufacturer Narrative
Additional information: b5.One ensite¿ precision¿ link sensor enabled was received for analysis.Inspection of the power inlet connector at the rear of the chassis confirmed, that one of the four pins is discolored or blackened.Functional testing revealed, no communication was able to be established.And a scu processor or logic voltage fault was displayed.The device history record was reviewed, to ensure that each manufacturing and inspection operation was performed.The review determined, that no non-conformances were identified that are related to the reported event.Based on the information provided to abbott and the investigation performed, the root cause of the field reported issue was isolated to an electrical arc at the rear power inlet connector from an undetermined event.

• 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: 11132560
• Report Number: 2184149-2021-00005
• Device Sequence Number: 837291
• Product Code: DQK
• UDI-Device Identifier: 05415067024756
• UDI-Public: 05415067024756
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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,Followup
• Report Date (Section B): 02/22/2021

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: 6757435
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/30/2020
• Supplement Date Received by Manufacturer: 02/22/2021
• Initial Report FDA Received Date: 01/07/2021
• Supplement Report FDA Received Date: 02/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other