MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. ENSITE PRECISION POWER CABLE; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number 100143451

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/17/2020

Event Type  Injury  

Manufacturer Narrative

The results, method and conclusion codes along with investigation results will be provided in the final report.

Event Description

During a procedure the power cable to the link was pulled out, causing the housing pins to break off.The patient was already prepared for the case when the procedure was cancelled.There were no adverse consequences to the patient.

Manufacturer Narrative

Additional information: d4, d10, g4, g7, h2, h3, h4, h6.One ensite precision¿ power supply was received into the lab for analysis.Visual inspection of the returned power supply module confirmed the reported issue as the four pin redel connector has been separated from the outer shell, or collar.Normal wear was indicated on the ps module and the wiring insulation was free of cuts, nicks and abrasions.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined the process was performed and completed in accordance with abbott specifications and procedures.Based on the information provided to abbott and the investigation performed, the root cause of the reported event was isolated to a detached redel connector body.The event which resulted in the physical damage to the connector body was not communicated and remains undetermined.

• Brand Name: ENSITE PRECISION POWER CABLE
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• MDR Report Key: 9910029
• MDR Text Key: 186762628
• Report Number: 2184149-2020-00039
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• PMA/PMN Number: K172396
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/30/2020

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
• Device Operator: Health Professional
• Device Model Number: 100143451
• Device Lot Number: 6507559
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/17/2020
• Initial Date FDA Received: 04/01/2020
• Supplement Dates Manufacturer Received: 04/21/2020
• Supplement Dates FDA Received: 04/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other