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

Model Number 439878

Device Problems Therapy Delivered to Incorrect Body Area (1508); Human-Device Interface Problem (2949); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Undesired Nerve Stimulation (1980)

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient sometimes feels pulsing on the left rib cage.The patient noted ¿it just kicks off, kicks off, kicks off.I cannot sleep on my left side anymore.If i hunch over, that's when i feel it." follow up confirmed the patient was experiencing phrenic nerve stimulation due to the left ventricular (lv) lead.The patient will be brought into the clinic and the settings will be updated.The lead remains in use.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: 7739770
• MDR Text Key: 115707168
• Report Number: 2649622-2018-12541
• Device Sequence Number: 0
• Product Code: OJX
• Reporter Country Code: US
• PMA/PMN Number: P080006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/30/2019
• Device Model Number: 439878
• Device Catalogue Number: 439878
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2018
• Date Device Manufactured: 02/10/2017
• 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: 5076-45 LEAD, DTMB1QQ ICD, 6935M55 LEAD
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR