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U.S. Department of Health and Human Services

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

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MEDTRONIC, INC. ATTAIN ABILITY MRI SURESCAN; DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE Back to Search Results
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.
 
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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 Key9979576
MDR Text Key190328376
Report Number2182208-2020-00756
Device Sequence Number1
Product Code OJX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P080006
Number of Events Reported1
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
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number4196
Device Catalogue Number4196
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/06/2020
Initial Date FDA Received04/20/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age54 YR
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