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

Model Number 419688

Device Problems Capturing Problem (2891); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Muscle Stimulation (1412); Undesired Nerve Stimulation (1980); Discomfort (2330); Sleep Dysfunction (2517)

Event Date 07/19/2018

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 called to report having ¿phrenic nerve/diaphragmatic stimulation¿ back at implant a year ago and was corrected.The patient noted the it ¿has now returned¿.Patient is experiencing discomfort and inability to sleep.Follow up was conducted at the patient¿s clinic.The nurse confirmed the patient had called shortly after implant and had experienced diaphragmatic/phrenic stimulation on the left ventricular (lv) lead.The lead was reprogrammed.The patient¿s current clinic was also contacted, and they also confirmed the patient is currently having daily diaphragmatic stimulation and increased threshold on the lv lead.The lead remains in use.No further patient complications have been reported as a result of this event.

• Brand Name: ATTAIN ABILITY 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: 9043118
• MDR Text Key: 158600627
• Report Number: 2649622-2019-16601
• Device Sequence Number: 1
• Product Code: OJX
• UDI-Device Identifier: 00643169860032
• UDI-Public: 00643169860032
• 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: consumer,health professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/06/2019
• Device Model Number: 419688
• Device Catalogue Number: 419688
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/23/2019
• Date Device Manufactured: 07/12/2017
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR