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

Model Number 419688

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Pleural Effusion (2010)

Event Date 05/27/2011

Event Type  Injury  

Event Description

It was reported that the left ventricular (lv) lead was dislodged.It was noted that intraoperative difficult location of lv lead due to difficult anatomy of cardiac coronary sinus (cs)/vein anatomy.Chest x-ray and echocardiogram identified basal pleura effusion on both sides.The lead was reprogrammed and an epicardial lead was implanted at a later date.The patient is enrolled in the (b)(4) study.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

This event occurred outside the us where a similar model is distributed.All information provided is included in this report.Patient information is not generally available due to confidentiality concerns.Concomitant medical products: 5076-52, lead, (b)(6) 2011; mdt-lead, (b)(6) 2011.(b)(4).

• 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: 4682190
• MDR Text Key: 16467903
• Report Number: 2649622-2015-04671
• Device Sequence Number: 1
• Product Code: OJX
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P080006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/31/2011

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 419688
• Device Catalogue Number: 419688
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/31/2011
• 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: D234TRK ICD
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 00059 YR