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

Model Number 459878

Device Problems Electrical /Electronic Property Problem (1198); High impedance (1291); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Muscle Stimulation (1412)

Event Date 05/05/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that there an alert for out of range, high left ventricular (lv) lead impedance, which led to a polarity switch to a unipolar configuration.It was noted the patient experienced extracardiac stimulation in the unipolar configuration.The lv lead was reprogrammed and 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.

Manufacturer Narrative

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

Event Description

Additional information reported the lv lead was programmed off.

• Brand Name: ATTAIN PERFORMA S MRI SURESCAN
• 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: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 8680654
• MDR Text Key: 147389426
• Report Number: 2649622-2019-09835
• Device Sequence Number: 1
• Product Code: OJX
• UDI-Device Identifier: 00643169601864
• UDI-Public: 00643169601864
• 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: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/15/2019

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/18/2020
• Device Model Number: 459878
• Device Catalogue Number: 459878
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/14/2019
• Initial Date FDA Received: 06/07/2019
• Supplement Dates Manufacturer Received: 06/10/2019; 08/09/2019
• Supplement Dates FDA Received: 06/12/2019; 08/15/2019
• Date Device Manufactured: 05/10/2018
• 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: W4TR01 CRTD, 5076-52 LEAD, 5076-58 LEAD
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR