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

Model Number 429688

Device Problems Failure to Capture (1081); High Capture Threshold (3266); Unstable Capture Threshold (3269)

Patient Problem Syncope (1610)

Event Date 12/07/2015

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 lead was not returned for analysis.However, performance data collected from the device was received and analyzed.Analysis of the device memory indicated pacing capture threshold in the rv (right ventricle) was elevated.Right ventricular capture threshold is variable butis generally greater than 2v from (b)(6) 2014 to (b)(6) 2016.(b)(4).

Event Description

It was reported that the right ventricular (rv) lead and left ventricular (lv) lead had high and variable thresholds with loss of capture after the patient had a fall.The patient also complained of syncope when laying on their side the leads were reprogrammed and remain 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 PLUS
• 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: 5557389
• MDR Text Key: 42231436
• Report Number: 2649622-2016-03252
• Device Sequence Number: 1
• Product Code: OJX
• Combination Product (y/n): N
• Reporter Country Code: SF
• 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: 01/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/10/2014
• Device Model Number: 429688
• Device Catalogue Number: 429688
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/08/2013
• 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
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 00075 YR