MAUDE Adverse Event Report: MEDTRONIC ZONE IND. SUD FRANCE S.A.; ELECTRODE, PACEMAKER, TEMPORARY

Model Number 6416-200

Device Problem Disconnection (1171)

Patient Problem Cardiac Arrest (1762)

Event Date 07/29/2015

Event Type  Injury  

Manufacturer Narrative

The information submitted reflects all relevant data received.If additional relevant information is received, a supplemental report will be submitted.Without a lot number or device serial number, the manufacturing date cannot be determined.(b)(4).

Event Description

It was reported that the patient who was on a temporary pacer coded after the electrode became disconnected from the patient cable.Fluoroscopy was used and threshold testing was done with "good capture." the temporary system was replaced with an implantable system the following day.No further patient complications have been reported as a result of this event.

• Type of Device: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): MEDTRONIC ZONE IND. SUD FRANCE S.A.; route d'anor 59610, fourmies,; fourmies 59610 ; FR 59610
• 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: 5120610
• MDR Text Key: 27296832
• Report Number: 6000022-2015-00003
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K973360
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Service Personnel
• Type of Report: Followup
• Report Date: 07/30/2015

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 6416-200
• Device Catalogue Number: 6416-200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/01/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/07/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 00043 YR