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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 Pacemaker Found in Back-Up Mode (1440); Battery Problem: High Impedance (2947)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/07/2020
Event Type  malfunction  
Manufacturer Narrative
Analysis of the expertise files is sufficient to identify the root cause of the event. No expertise of the returned device is deemed necessary. 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, the subject crt-p was interrogated on (b)(6) 2020 before implantation. Several pop-up messages showed that the device had switched in standby mode. The device was then re-initialized, as confirmed by subsequent pop-up messages. After re-initialization, it was observed that the battery impedance was 2. 56kohms. The subject crt-p was not implanted. Preliminary analysis results confirmed the reported switch in standby mode, and revealed that it was due to a very specific and rare communication error that occurred upon device interrogation. However, there was no corruption in the device implant memories, and the device was successfully re-initialized during the follow-up. In addition, analysis confirmed that there was no issue at the level of the battery impedance.
 
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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 Key10481907
MDR Text Key206368026
Report Number1000165971-2020-00581
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeSP
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 12/03/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/02/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/09/2020
Device Model NumberREPLY CRT-P
Device Catalogue NumberREPLY CRT-P
Device Lot NumberS0375
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/26/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date08/07/2020
Event Location Hospital
Date Manufacturer Received11/13/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/09/2019
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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