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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 Problems Display or Visual Feedback Problem (1184); Premature End-of-Life Indicator (1480)
Patient Problems No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/22/2020
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 microport crm that was cleared or approved by fda for marketing in the united states.
 
Event Description
Reportedly, during a follow-up performed on (b)(6) 2020, a message stating that the crt-p had reached its end of life (eol) was displayed. The battery impedance curve showed a sudden increase to 20 kohms. Nevertheless, the battery impedance was measured at 5. 12 kohms on (b)(6) 2020 and the remaining time to recommended replacement time (rrt) was at minimum 5 months. Upon a second interrogation attempt, similar abnormal battery impedance curve was observed. It was decided to reprogram the atrial and ventricular output to 7 v. Consequently, the time to rrt decreased to 3 months. Preliminary analysis revealed that the reported behavior is related to a software issue.
 
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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
146013429
MDR Report Key10834584
MDR Text Key217696933
Report Number1000165971-2020-00712
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeNL
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Physician Assistant
Type of Report Initial,Followup,Followup,Followup
Report Date 03/30/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/13/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/12/2017
Device Model NumberREPLY CRT-P
Device Catalogue NumberREPLY CRT-P
Device Lot NumberS0086
Was Device Available for Evaluation? No
Date Returned to Manufacturer12/10/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date10/22/2020
Event Location Hospital
Date Manufacturer Received03/04/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/12/2015
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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