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); Low impedance (2285)

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

Event Date 09/01/2015

Event Type  Injury  

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.Product event summary: the proximal segment of the lead was returned, analyzed and the outer insulation of the lead developed a breach due to a depression while in vivo.Performance data collected from the device was received and analyzed.Analysis of the device memory indicated the criteria for the right ventricular lead integrity alert were met, the impedance on the rv (right ventricular) pacing lead was beyond the expected upper range, and oversensing due to non-physiologic signals/sic (sensing integrity counter).(b)(4).

Event Description

It was reported that the right ventricular (rv) lead exhibited high impedance, sensing integrity counter (sic), and non-sustained ventricular tachycardia (vt) episodes resulting from a possible fracture.In addition, the pacing lead exhibited low pacing impedance and oversensing noise.The rv lead and pacing lead were explanted and replaced.No patient complications have been reported as a result of this event.

• 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: 5272666
• MDR Text Key: 32861819
• Report Number: 2182208-2015-03951
• Device Sequence Number: 1
• Product Code: DTD
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K915724
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 6984M
• Device Catalogue Number: 6984M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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: 693565 LEAD
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 00044 YR