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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT CRM S.R.L. REPLY PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)

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MICROPORT CRM S.R.L. REPLY PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P) Back to Search Results
Model Number REPLY CRT-P
Device Problem Display or Visual Feedback Problem (1184)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/12/2021
Event Type  malfunction  
Event Description
Reportedly, when the first atrial sensing test is performed, no atrial markers are visible and no values are displayed. The same has been observed with several reply crt-p devices.
 
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.
 
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Brand NameREPLY
Type of DevicePULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)
Manufacturer (Section D)
MICROPORT CRM S.R.L.
via crescentino s.n
saluggia (vc) 13040
IT 13040
Manufacturer (Section G)
MICROPORT CRM S.R.L.
via crescentino s.n
saluggia (vc) 13040
IT 13040
Manufacturer Contact
elodie vincent
via crescentino s.n
saluggia (vc) 13040
IT   13040
MDR Report Key12791165
MDR Text Key280684038
Report Number1000165971-2021-01508
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/05/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/10/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberREPLY CRT-P
Device Catalogue NumberREPLY CRT-P
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received01/05/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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