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

Model Number 429888

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Syncope (1610); Thrombus (2101)

Event Date 07/11/2016

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: 6949-65 lead, implanted (b)(6) 2006.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient presented to the emergency room with abdominal pain and was admitted with possible cholecystitis.Iv antibiotics were administered.Further evaluation revealed there was no acute intra-abdominal process.The patient had syncope and there was concern for heart failure exacerbation.A transthoracic echocardiogram revealed a mobile mass on or near the right atrial (ra) lead.A transesophageal echocardiogram revealed a large burden of highly mobile masses on the leads.A series of blood cultures were negative.There was no evidence of infection or endocarditis.A venous duplex scan revealed acute venous thrombus of the right arm.The patient was treated with heparin and subsequently developed a drop in platelet count and heparin induced thrombocytopenia.Heparin was discontinued and argatroban was started.It was noted that the masses were likely not acute and did not play a role in the patient¿s hospitalization.The patient was discharged home and the leads remain in use.The patient is a participant in the product surveillance registry.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 PERFORMA
• 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: 6012603
• MDR Text Key: 56911492
• Report Number: 2649622-2016-13740
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/09/2016
• Device Model Number: 429888
• Device Catalogue Number: 429888
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/18/2016
• Initial Date FDA Received: 10/07/2016
• Supplement Dates Manufacturer Received: 07/18/2016
• Supplement Dates FDA Received: 09/25/2017
• Date Device Manufactured: 12/30/2014
• 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: DTBA1QQ ICD, 6935M-62 LEAD, 5076-52 LEAD
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 54 YR