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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 Premature Discharge of Battery (1057)
Patient Problem Insufficient Information (4580)
Event Date 06/30/2021
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 microport crm that was cleared or approved by fda for marketing in the united states.
 
Event Description
The resynchronization system was implanted on (b)(6) 2017. Reportedly, premature battery depletion occurred. The crt-p was replaced on (b)(6) 2021 since it had reached its end of service (eos).
 
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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 Key12225183
MDR Text Key263405028
Report Number1000165971-2021-00574
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeSZ
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 11/05/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/26/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/11/2017
Device Model NumberREPLY CRT-P
Device Catalogue NumberREPLY CRT-P
Device Lot NumberS0171
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/15/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/11/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/11/2016
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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