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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IPG MFG SWITZERLAND REVEAL LINQ DETECTOR AND ALARM, ARRHYTHMIA

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IPG MFG SWITZERLAND REVEAL LINQ DETECTOR AND ALARM, ARRHYTHMIA Back to Search Results
Model Number LNQ11
Device Problem Premature Discharge of Battery (1057)
Patient Problem No Information (3190)
Event Date 11/29/2016
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 had a medical complication/injury and the implantable cardiac monitor (icm) was explanted. Additionally, it was reported that the implantable cardiac monitor (icm) device reached recommended replacement time (rrt) earlier than expected. 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
Corrected: this device was reported as included in the field action noted but returned product investigation found the device did not perform as described in the field action. The device is no longer included as part of the field action. Product event summary: the device was returned and analyzed. Analysis of the returned device was inconclusive. The device met 86% of expected longevity. Without the history of the programmed settings throughout its service life, there is no way to determine why the longevity did not match the predicted model. Further analysis did not confirm the reported low battery impedance. The device was fully functional with nominal system current drain, regulated supply voltages and reference voltages. The stacked chip scale package, containing the hybrid¿s integrated circuits, passed diagnostic system testing. However, battery was misplaced during analysis and was not tested.
 
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Brand NameREVEAL LINQ
Type of DeviceDETECTOR AND ALARM, ARRHYTHMIA
Manufacturer (Section D)
IPG MFG SWITZERLAND
route du molliau 31
tolochenaz 1131
CH 1131
Manufacturer (Section G)
IPG MFG SWITZERLAND
route du molliau 31
tolochenaz 1131
CH 1131
Manufacturer Contact
paula bixby
8200 coral sea st ne
mounds view, MN 55112
7635055378
MDR Report Key6208777
MDR Text Key163398946
Report Number9614453-2016-07700
Device Sequence Number1
Product Code DSI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K132649
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup,Followup,Followup
Report Date 10/21/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/14/2015
Device Model NumberLNQ11
Device Catalogue NumberLNQ11
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/05/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/11/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/15/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-1249-2016

Patient Treatment Data
Date Received: 12/28/2016 Patient Sequence Number: 1
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