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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 Failure to Interrogate (1332)
Patient Problem No Information (3190)
Event Date 05/21/2019
Event Type  malfunction  
Manufacturer Narrative
The company opened a capa to investigate late reporting issues.After a retrospective review, this complaint was found to be reportable to the us fda and is therefore reported now.
 
Event Description
Reportedly, on (b)(6) 2019, it was observed that the programming head failed to interrogate two pacemakers.The head was plugged off and plugged in, but the issue persisted.
 
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, on (b)(6)2019 , it was observed that the programming head failed to interrogate two pacemakers.The head was plugged off and plugged in, but the issue persisted.
 
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Brand Name
SMARTTOUCH
Type of Device
PROGRAMMER, PACEMAKER
Manufacturer (Section D)
MANUFACTURED FOR MICROPORT CRM S.R.L.
parc d'affaires noveos 4 avenue réaumur
clamart, 92140
FR 
MDR Report Key10244642
MDR Text Key198693496
Report Number1000165971-2020-00483
Device Sequence Number1
Product Code KRG
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
Report Date 07/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/08/2020
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? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date05/21/2019
Event Location Hospital
Date Manufacturer Received07/08/2020
Patient Sequence Number1
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