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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT CRM S.R.L. OTO; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
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MICROPORT CRM S.R.L. OTO; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) Back to Search Results
Model Number OTO DR
Device Problem Missing Test Results (3267)
Patient Problem No Information (3190)
Event Date 04/16/2020
Event Type  malfunction  
Manufacturer Narrative
The device involved in this mdr report is not approved in the united states; however, it is similar to a device manufactured by sorin that was cleared or approved by fda for marketing in the united states.
 
Event Description
Reportedly, during the first interrogation after implantation, the patient data and parameters were programmed.Pacing and sensing tests were also performed.However, the test results were not printed in the report.When the user ended the session and re-interrogated the pacemaker, all the test results were printed.
 
Manufacturer Narrative
Preliminary analysis results showed that the device behaved as specified.
 
Event Description
Reportedly, during the first interrogation after implantation, the patient data and parameters were programmed.Pacing and sensing tests were also performed.However, the test results were not printed in the report.When the user ended the session and re-interrogated the pacemaker, all the test results were printed.
 
Event Description
Reportedly, during the first interrogation after implantation, the patient data and parameters were programmed.Pacing and sensing tests were also performed.However, the test results were not printed in the report.When the user ended the session and re-interrogated the pacemaker, all the test results were printed.
 
Manufacturer Narrative
Please refer to the attached analysis report.- attachment: [20200807 - file-2020-00991 - analysis and closure report - resp-2020-00748.Pdf].
 
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Brand Name
OTO
Type of Device
IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
Manufacturer (Section D)
MICROPORT CRM S.R.L.
parc d'affaires noveos 4 avenue reaumur
clamart 92140
FR  92140
MDR Report Key10014260
MDR Text Key189739880
Report Number1000165971-2020-00388
Device Sequence Number1
Product Code LWP
UDI-Device Identifier08031527017228
UDI-Public(01)08031527017228(11)190304(17)210304
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup,Followup
Report Date 08/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/30/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/04/2021
Device Model NumberOTO DR
Device Catalogue NumberOTO DR
Device Lot NumberS0355
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date04/16/2020
Event Location Hospital
Date Manufacturer Received08/07/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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