MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. IBI¿ 1400-CV CARDIOVERSION II SWITCH BOX; SYSTEM, PACING, TEMPORARY, ACUTE, INTERNAL ATRIAL DEFIBRILLATION

Model Number 85432

Device Problem Failure to Deliver Shock/Stimulation (1133)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/14/2019

Event Type  Injury  

Event Description

During an electrophysiology procedure, a cancellation occurred due to the inability to deliver electric shock.The issue could not be resolved and the procedure was cancelled.There were no adverse patient consequences.

Manufacturer Narrative

One cardioversion ii switch box was received for evaluation.During visual inspection it was confirmed the device was damaged and had broken switches.Functional testing could not be performed as the switches would not turn making the device nonfunctional.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.The reported inability to deliver electric shock and subsequent procedure cancellation could not be confirmed as the device could not be tested in the condition received.

• Brand Name: IBI¿ 1400-CV CARDIOVERSION II SWITCH BOX
• Type of Device: SYSTEM, PACING, TEMPORARY, ACUTE, INTERNAL ATRIAL DEFIBRILLATION
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 2375 morse ave; irvine CA 92614
• MDR Report Key: 8315917
• MDR Text Key: 135417632
• Report Number: 2030404-2019-00008
• Device Sequence Number: 1
• Product Code: MTE
• Combination Product (y/n): N
• PMA/PMN Number: P020052
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 85432
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other