MAUDE Adverse Event Report: MEDTRONIC, INC. ATTAIN ABILITY; DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE

Model Number 4196

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Syncope (1610); Vascular Dissection (3160)

Event Date 01/24/2017

Event Type  Injury  

Manufacturer Narrative

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 experienced a vascular dissection during implant of the left ventricular (lv) lead.It was noted the first lv lead was implanted, however, due to patient anatomy, a high pacing threshold was observed.The physician removed the lv lead and replaced it with a different lv lead.After the procedure, the patient's blood pressure could not be measured due to a suspected vascular dissection.It was then noted the patient fainted following the implant procedure.The patient presented to the hospital and a left ventricular (lv) lead revision procedure was performed.The patient status was stable and the lv lead remains in use.No further 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: ATTAIN ABILITY
• Type of Device: DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE
• 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: 6466507
• MDR Text Key: 72068982
• Report Number: 2182208-2017-00423
• Device Sequence Number: 1
• Product Code: OJX
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P080006
• 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,Followup
• Report Date: 01/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 4196
• Device Catalogue Number: 4196
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/24/2017
• Initial Date FDA Received: 04/06/2017
• Supplement Dates Manufacturer Received: 01/24/2017
• Supplement Dates FDA Received: 10/02/2017
• 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: G20A1 DEVICE
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 64 YR