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

Model Number 5866-38M

Device Problems Low impedance (2285); High Capture Threshold (3266)

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

Event Date 08/19/2016

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: 694765 lead, implanted: (b)(6) 2010; d224trk crt-d, implanted: (b)(6) 2013.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient's left ventricular (lv) lead configuration consisting of two leads connected via an adaptor to the patient's cardiac resynchronization therapy defibrillator (crt-d) was exhibiting low lv pacing impedance and high lv pacing thresholds.The two leads were capped and replaced and the adaptor was explanted.No patient complications have been reported as a result of this event.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: TWO IS-1 UNI LEADS TO IS-1 BI IPG ADAPTOR 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, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 6006732
• MDR Text Key: 56772714
• Report Number: 2182208-2016-02337
• Device Sequence Number: 1
• Product Code: DTD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K911302
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/14/2014
• Device Model Number: 5866-38M
• Device Catalogue Number: 5866-38M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/19/2016
• Date Device Manufactured: 06/29/2012
• 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: 5071-53 LEAD, 694965 LEAD, 5076-52 LEAD
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 67 YR