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

Model Number 419588

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/22/2015

Event Type  Injury  

Manufacturer Narrative

Continuation of medical devices: 694775 lead implanted (b)(6) 2010; dtba1d1 icd implanted (b)(6) 2014.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the left ventricular (lv) lead was non-functioning.The lead was capped and replaced.No patient complications have been reported as a result of this event.

• 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: 7257314
• MDR Text Key: 99536059
• Report Number: 2649622-2018-02162
• Device Sequence Number: 1
• Product Code: OJX
• UDI-Device Identifier: 00885074511955
• UDI-Public: 00885074511955
• 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
• 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: 06/10/2011
• Device Model Number: 419588
• Device Catalogue Number: 419588
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2017
• Date Device Manufactured: 05/18/2010
• 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): Hospitalization; Required Intervention
• Patient Age: 46 YR