MAUDE Adverse Event Report: MEDTRONIC, INC.; CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)

Model Number 5487

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Cardiac Arrest (1762)

Event Date 10/12/2014

Event Type  Injury  

Event Description

It was reported that during the hospitalization for the implant of a trans-catheter aortic valve replacement (tavr) the temporary pacing lead became loose and detached from the cable while the patient was sitting up in bed.The patient coded was intubated and on a respirator.As a result the patient was in asystole.The patient was later implanted with a pacing system.The temporary pacing lead will not be returned for analysis as it was lost.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

The information submitted reflects all relevant data received.If additional relevant information is received, a supplemental report will be submitted.(b)(4).

• Type of Device: CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer (Section G): MEDTRONIC CARDIAC RHYTHM HEART FAILURE; 8200 coral sea st ne; mounds view MN 55112
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 4316416
• MDR Text Key: 5247194
• Report Number: 2182208-2014-03557
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K960446
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 5487
• Device Catalogue Number: 5487
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/13/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 00080 YR