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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 Consequences Or Impact To Patient (2199)
Event Date 07/28/2020
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, when interrogating a paradym vr device, the error message 'interrogation impossible' was displayed with the following suggestions: end the session and try to interrogate the device again. If the previous point does not work, use the emergency programming. Contact your sorin representative. It was still impossible to interrogate the implant after several tests and by trying the suggested methods. However, successful interrogation could be conducted with an orchestra plus programmer. After the follow-up, a new attempt to interrogate the icd with the associated tablet could be performed without issue. It should be noted that a week earlier, the tablet remained blocked and inoperable leading to a restart by battery removal.

 
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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 Key10437521
MDR Text Key204195851
Report Number1000165971-2020-00564
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,Followup
Report Date 10/30/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/21/2020
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 Manufacturer08/17/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date07/28/2020
Event Location Hospital
Date Manufacturer Received10/16/2020
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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