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

Model Number	H702475
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.Further information regarding the event were requested but not received.
Event or Problem Description
Related manufacturer reference: 2184149-2019-00143.During preparation, a spark was noted when using the precision link power input.Some of the pins appeared to have fused together.There was no patient involved.
Additional Manufacturer Narrative
One ensite¿ precision¿ link sensor enabled was received for evaluation.Visual inspection of the returned product revealed a redel connector assembly from the psu (power supply unit) which was stuck in the power inlet connector.Inspection of the power inlet connector revealed discoloration at one of the electrical contact pins due to an electrical short circuit.Power was applied to the returned product which initialized as anticipated.Based on the information provided to abbott and the investigation performed, the root cause of the field reported event was isolated to a dislodged power supply connector assembly and subsequent shorted electrical contacts.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.
Event or Problem Description
The cable produced the spark when it was attached to the link.

• 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: 8851348
• Report Number: 2184149-2019-00142
• Device Sequence Number: 1504248
• Product Code: DQK
• UDI-Device Identifier: 05415067024756
• UDI-Public: 05415067024756
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K172396
• 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): 08/13/2019

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 Lot Number: 5795622
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/17/2019
• Supplement Date Received by Manufacturer: 08/02/2019
• Initial Report FDA Received Date: 08/01/2019
• Supplement Report FDA Received Date: 08/13/2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ENSITE PRECISION¿ POWER CABLE; ENSITE PRECISION¿ POWER CABLE