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

Model Number 419688

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

Patient Problems Syncope (1610); Dyspnea (1816)

Event Date 08/24/2015

Event Type  Injury  

Manufacturer Narrative

The information submitted reflects all relevant data received.If additional relevant information is received, a supplemental report will be submitted.Product event summary: the lead was not returned for analysis.However, performance data collected from the device was received and analyzed.There were no anomalies found.(b)(4).

Event Description

It was reported that the patient was admitted to the hospital after an episode of syncope.The patient also reported increased shortness of breath over the past number of months.It was found that the patient's left ventricular (lv) lead had high thresholds and no capture.The lv lead was reprogrammed off and remains in the patient.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): 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: 5424991
• MDR Text Key: 37908159
• Report Number: 2649622-2016-02492
• Device Sequence Number: 1
• Product Code: OJX
• 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,consum
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/09/2015
• Device Model Number: 419688
• Device Catalogue Number: 419688
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/19/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/23/2014
• 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: 6947M62 LEAD, 5076-52 LEAD, DTBA1D4 ICD
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 00058 YR