MAUDE Adverse Event Report: MPRI ATTAIN ABILITY; DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE

Model Number 419678

Device Problem High Capture Threshold (3266)

Patient Problems Syncope (1610); Hematoma (1884)

Event Date 11/26/2017

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: dtba1d1 crt-d, implanted: (b)(6) 2014.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient presented to the emergency room due to syncope and facial hematoma.The left ventricular (lv) lead showed high threshold.The lv lead output was increased and remains in use.No further patient complications have been reported as a result of this event.

• Brand Name: ATTAIN ABILITY
• Type of Device: DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer (Section G): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 7256714
• MDR Text Key: 99572365
• Report Number: 2649622-2018-01849
• Device Sequence Number: 1
• Product Code: OJX
• UDI-Device Identifier: 00613994469724
• UDI-Public: 00613994469724
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P080006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/25/2010
• Device Model Number: 419678
• Device Catalogue Number: 419678
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/27/2017
• Date Device Manufactured: 10/08/2009
• 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
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 73 YR