MAUDE Adverse Event Report: MEDTRONIC, INC.; MAGNET, TEST, PACEMAKER

Model Number MDT-SLITTER

Device Problem Accessory Incompatible (1004)

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

Event Date 05/13/2015

Event Type  malfunction  

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).

Event Description

It was reported that during the implant procedure of the left ventricular (lv) lead, after all the leads were placed, physician slit the lv sheath and the lv lead completely dislodged from the posterior-lateral vein.The lv lead was removed and exchanged for another lead.Physician believed the event was related to the sheath and slitter.No patient complications have been reported as a result of this event.The patient is a participant in the sensor optimization of cardiac resynchronization therapy response clinical study.

Event Description

It was further reported that patient encountered a hematoma and sandbag placed over right femoral artery puncture performed, no treatment was necessary.Pi assessed event as research procedure related and not serious.

• Type of Device: MAGNET, TEST, PACEMAKER
• 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: 4970302
• MDR Text Key: 23549798
• Report Number: 2182208-2015-02448
• Device Sequence Number: 1
• Product Code: DTG
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 05/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MDT-SLITTER
• Device Catalogue Number: MDT-SLITTER
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/01/2015
• 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