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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 Failure to Interrogate (1332)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/04/2021
Event Type  malfunction  
Manufacturer Narrative
The device model involved in this mdr 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
During the implantation of the subject crt-p on (b)(6) 2021, the physician did not observe any particular problem during the procedure. During his check-up before the patient was discharged from surgery, he was unable to communicate with the device and to check its correct operation with an orchestra+ programmer. After several complete restarts of the programmer, verification of the correct positioning of the cpr3 head (which had several leds lit), it was impossible to communicate with the device. He observed the same malfunction when using a smartouch programmer. He therefore decided to re-intervene on the patient and replace the subject device with another brand device. After explantation, it was possible to communicate with the pacemaker with the cpr3 head of the orchestra+ in contact with the device. Several other microport crm devices were implanted on the same day in this operating room with the same programmer without encountering any communication failure.
 
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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
laura ouaki
via crescentino s.n.
saluggia (vc), 13040
IT   13040
MDR Report Key12093178
MDR Text Key259203799
Report Number1000165971-2021-00529
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial
Report Date 06/30/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/30/2021
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
Device Lot NumberS0470
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/03/2020
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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