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

Model Number 419578

Device Problems Premature Elective Replacement Indicator (1483); Battery Problem (2885); Capturing Problem (2891); High Capture Threshold (3266)

Patient Problems Muscle Stimulation (1412); Dyspnea (1816)

Event Date 02/13/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: 693565 lead implanted: (b)(6) 2010; 383059 lead implanted: (b)(6) 2010.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported the left ventricular (lv) lead displayed increased thresholds which affected the battery life of the cardiac resynch ronization therapy defibrillator (crt-d).The lv lead was inactivated however the patient experienced dyspnea on exertion and the lead was turned back on.It was further reported there was chronic left diaphragmatic stimulation.As the stimulation did not bother the patient, only the generator change was performed due to elective replacement indicator (eri).The lead remains in use and the device was explanted and replaced.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 STARFIX
• 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: 7671016
• MDR Text Key: 113459981
• Report Number: 2649622-2018-11076
• Device Sequence Number: 1
• Product Code: OJX
• UDI-Device Identifier: 00885074511986
• UDI-Public: 00885074511986
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P060039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/22/2010
• Device Model Number: 419578
• Device Catalogue Number: 419578
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2018
• Date Device Manufactured: 05/27/2009
• 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
• Treatment: DTBA1D1 CRTD
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 60 YR