MAUDE Adverse Event Report: MEDTRONIC, INC. IS-1 BI LEAD TO IS-1 BI IPG - PERMANENT LEAD EXTENSION KIT; ADAPTOR, LEAD, PACEMAKER

Model Number 6984M

Device Problems Signal Artifact/Noise (1036); Pacing Problem (1439)

Patient Problems Pain (1994); Discomfort (2330)

Event Date 11/13/2014

Event Type  malfunction  

Event Description

It was reported that the patient is pacing dependent and the right ventricular (rv) lead exhibited noise that was causing pacing inhibition.The pacing system was implanted in the patient¿s belly and the leads were tunneled through the intercostal muscle.The patient experienced pain and discomfort in the area around the lead exiting the intercostal space.It was noted that the rv lead used a lead extender, which is sitting on the patient¿s rib.The noise is seen when the patient sits up and bends to the left.The lead was reprogrammed and it remains in use.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.Concomitant medical products: 5054-52 lead.A 5554-45 lead, implanted (b)(6) 2002.(b)(4).

• Brand Name: IS-1 BI LEAD TO IS-1 BI IPG - PERMANENT LEAD EXTENSION KIT
• Type of Device: ADAPTOR, LEAD, 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: 4498463
• MDR Text Key: 19087643
• Report Number: 2182208-2015-00531
• Device Sequence Number: 1
• Product Code: DTD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K915724
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/13/2015
• Device Model Number: 6984M
• Device Catalogue Number: 6984M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2014
• Date Device Manufactured: 12/20/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: DTBA1D1 ICD, 6721S-50 X2 LEAD
• Patient Age: 00048 YR
• Patient Weight: 50