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

Model Number 4196

Device Problems Signal Artifact/Noise (1036); Device-Device Incompatibility (2919)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/01/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: competitor pacing lead, competitor system for phrenic nerve stimulation.Medtronic was made aware of this event through a search of literature publications.It was not possible to ascertain specific device information from the literature publication or to match the event with previously reported events.This information is based entirely on journal literature.All information provided is included in this report.Without a lot number or device serial number, the manufacturing date cannot be determined.Since no device id was provided, it is unknown if this event has been previously reported.A request for additional information will be made and upon receipt a supplemental report will be submitted accordingly.Referenced article: ¿first report of concomitant subcutaneous defibrillator and phrenic nerve stimulator implantation in a patient with severe central sleep apnea and left ventricular systolic dysfunction.¿ heartrhythm case reports.2020; 6(1):44-47.Doi: 10.1016/j.Hrcr.2019.10.004.If information is provided in the future, a supplemental report will be issued.

Event Description

The literature publication reported the following complaint regarding this lead model.The patient had previously had an implantable cardioverter defibrillator (icd) system in place due to severe ischemic cardiomyopathy.The patient also had worsening central sleep apnea (csa).The need arose for further treatment to alleviate the potential complications of the sleep apnea.Of note, the patient was not able to treat it with continuous positive airway pressure (cpap), or other therapies; and the patient indicated that the symptoms were not improving.The decision was made to implant a phrenic nerve stimulation (pns) system to treat the csa.The icd system was temporarily disabled to allow for electrocautery.The patient then underwent the procedure to implant the pns system for the csa.Two pacing leads were implanted; one to be used for ¿monitoring transthoracic impedance.¿ due to the patient having an existing icd, the device-device interaction needed to be assessed.The icd was re-enabled.The pns system was activated, and ¿pacing artifacts¿ were seen in the primary and secondary vectors, but not in the alternate.Even though the pacing artifact was ¿visible,¿ it was not sensed as ¿noise.¿ during the impedance check, the patient¿s sinus beat taken before the impedance check, was labeled as ¿noise.¿ the icd¿s sensing vector was programmed as secondary.The leads were then connected to the generator and the system was implanted in a right pectoral pocket.The pns system was activated, so that the leads could ¿settle in and stabilized.¿ the patient was discharged the next day and six weeks later was brought back to activate the pns system.The device-device interaction was assessed the same way as during the initial implantation.It was further noted that there was no noise detected with the pacing output as directed.However, with impedance testing, ¿artifact¿ which was similar to what was seen during implant was present, but this finding was not able to be reproduced.The pns system was activated.Six weeks after the activation of the pns system, the patient reported ¿feeling better.¿ interrogation of the icd did not reveal any shocks.Further checking was schedule for two months post-implantation.The status/location of the lead is unknown; but appears to be still in use.Further follow up did not yet yield any additional information.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): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer (Section G): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 9979576
• MDR Text Key: 190328376
• Report Number: 2182208-2020-00756
• 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: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 4196
• Device Catalogue Number: 4196
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/06/2020
• 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): Other
• Patient Age: 54 YR