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Model Number LNQ11 |
Device Problems
Over-Sensing (1438); Under-Sensing (1661); Invalid Sensing (2293)
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Patient Problems
Unspecified Infection (1930); Skin Erosion (2075); Discomfort (2330)
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Event Date 02/26/2013 |
Event Type
Injury
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Manufacturer Narrative
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This information is based entirely on journal literature.All information provided is included in this report.Multiple patients were noted in the article; however, a one to one correlation could not be made with unique product serial numbers.Patient information is limited due to confidentiality concerns.The gender of the baseline characteristics is male and the baseline age is (b)(6) years old.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.Request for additional information will be made and upon receipt a supplemental report will be submitted accordingly.Referenced article: ¿assessing arrhythmia burden after catheter ablation of atrial fibrillation using an implantable loop recorder: the abacus study.¿ journal of cardiovascular electrophysiology 2013;24:875-881.Doi: 10.1111/jce.12141.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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A journal article was reviewed that contained information regarding implantable loop recorders (ilr).Multiple patients were noted in the article; however, a one to one correlation could not be made with unique serial numbers with the available information provided.The author reported that there were patients who had false device detections; with the following ¿causes,¿ per the author: noise, t-wave oversensing (twos), and loss of electrode contact and/or poor electrode contact.The device also ¿falsely¿ detected/¿misclassified¿ asystole and ventricular tachycardia (vt) due to under/oversensing.There was also one patient who had skin erosion, and one patient who had pocket infection which required the device to be explanted.One patient requested the removal of the ilr due to ¿local discomfort.¿ one patient requested removal for ¿cosmetic reasons.¿ the status/location of the ilr is unknown.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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Manufacturer Narrative
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All information provided is included in this report.No further information is available.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Additional information was obtained through follow up with the author who indicated that there was no further information available.
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Search Alerts/Recalls
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