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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MANUFACTURED FOR MICROPORT CRM S.R.L. SMARTTOUCH PROGRAMMER, PACEMAKER

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MANUFACTURED FOR MICROPORT CRM S.R.L. SMARTTOUCH PROGRAMMER, PACEMAKER Back to Search Results
Model Number SMARTTOUCH CPR3H
Device Problem Interrogation Problem (4017)
Patient Problem No Information (3190)
Event Date 09/04/2020
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, the subject inductive telemetry head is not functional.

 
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Brand NameSMARTTOUCH
Type of DevicePROGRAMMER, PACEMAKER
Manufacturer (Section D)
MANUFACTURED FOR MICROPORT CRM S.R.L.
parc d'affaires noveos 4 avenue réaumur
clamart, 92140
FR
Manufacturer (Section G)
EOLANE BLD J. BAPTISTE COLBERT 49520 COMBREE FRANCE
parc d'affaires noveos 4 avenue réaumur
clamart, 92140
FR
Manufacturer Contact
laura ouaki
parc d'affaires noveos 4 avenue réaumur
clamart, 92140 
FR  
146013429
MDR Report Key10604687
MDR Text Key209555462
Report Number1000165971-2020-00617
Device Sequence Number1
Product Code KRG
Combination Product (Y/N)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 09/30/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/30/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberSMARTTOUCH CPR3H
Device Catalogue NumberSMARTTOUCH CPR3H
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/29/2020
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Distributor Facility Aware Date09/04/2020
Event Location No Information
Date Manufacturer Received09/04/2020
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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