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

Model Number 6416-140

Device Problem Device Or Device Fragments Location Unknown (2590)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/03/2014

Event Type  Injury  

Event Description

It was reported that the lead was placed in the atrium with no acceptable measurements so it was repositioned to another atrial location.Measurements were unacceptable again so the implanter attempted to take the lead out.The lead got stuck and about 15 rotations were needed to get the lead out.Once the lead was explanted the physician noticed that lead was missing its helix tip.The fluoroscopic picture did not show the tip in the atrium and it is unknown where it ended.No patient complications have been reported as a result of this event.

Manufacturer Narrative

This event occurred outside the us where the same model is distributed.All information provided is included in this report.Patient information is not generally available due to confidentiality concerns.(b)(4).

• Type of Device: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): MEDTRONIC ZONE IND. SUD FRANCE S.A.; route d'anor 59610, fourmies,; fourmies 5961 0; FR 59610
• Manufacturer (Section G): MEDTRONIC CARDIAC RHYTHM DISEASE MGMT; 8200 coral sea st ne; mounds view MN 55112
• Manufacturer Contact: nashoane fulwood-kelley ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635260583
• MDR Report Key: 3743728
• MDR Text Key: 4421607
• Report Number: 6000022-2014-00001
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K973360
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/16/2016
• Device Model Number: 6416-140
• Device Catalogue Number: 6416-140
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/04/2014
• 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; Required Intervention
• Patient Age: 00045 YR