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U.S. Department of Health and Human Services

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

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SORIN GROUP ITALIA S.R.L. - CRM FACILITY REPLY PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P) Back to Search Results
Model Number REPLY CRT-P
Device Problem No Pacing (3268)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/16/2017
Event Type  malfunction  
Manufacturer Narrative
Preliminary analysis showed no ecg to prove the lack of pacing but it's probably associated to noise when pm not yet in pocket/body and especially in the hands of physician.
 
Event Description
During a crt-d device replacement after disconnecting the rv lead and reconnection in the subject device the physician stopped the lv pacing. There was no pacing of the rv for about 7 seconds. The device was outside the pocket. Then, lv pacing was reactivated and pacing rate was set to 50 bpm. Pacing morphology became rv pacing with a rate of 70 (which should be the reply pacing at 70 bpm). Then the lv was connected to the reply. During this, several short periods of rv pacing inhibition, were visible. The device was put in the pocket which showed changing of the pacing spike (unipolar pacing).
 
Manufacturer Narrative
Please refer to the analysis report.
 
Event Description
During a crt-d device replacement after disconnecting the rv lead and reconnection in the subject device the physician stopped the lv pacing. There was no pacing of the rv for about 7 seconds. The device was outside the pocket. Then, lv pacing was reactivated and pacing rate was set to 50 bpm. Pacing morphology became rv pacing with a rate of 70 (which should be the reply pacing at 70 bpm). Then the lv was connected to the reply. During this, several short periods of rv pacing inhibition, were visible. The device was put in the pocket which showed changing of the pacing spike (unipolar pacing).
 
Manufacturer Narrative
The device model involved in this mdr report is not approved in the united states; however, it is similar to a device manufactured by livanova that was cleared or approved by fda for marketing in the united states.
 
Event Description
During a crt-d device replacement after disconnecting the rv lead and reconnection in the subject device the physician stopped the lv pacing. There was no pacing of the rv for about 7 seconds. The device was outside the pocket. Then, lv pacing was reactivated and pacing rate was set to 50 bpm. Pacing morphology became rv pacing with a rate of 70 (which should be the reply pacing at 70 bpm). Then the lv was connected to the reply. During this, several short periods of pacing inhibition, were visible. The device was put in the pocket which showed changing of the pacing spike (unipolar pacing).
 
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Brand NameREPLY
Type of DevicePULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)
Manufacturer (Section D)
SORIN GROUP ITALIA S.R.L. - CRM FACILITY
parc d'affaires noveos 4 avenue réaumur
.
clamart 92140
FR 92140
Manufacturer (Section G)
SORIN GROUP ITALIA SRL VIA CRESCENTINO 13040 SALUGGIA ITALY
parc d'affaires noveos 4 avenue réaumur
.
clamart 92140
FR 92140
Manufacturer Contact
elodie vincent
parc d'affaires noveos 4 avenue réaumur
.
clamart 92140
FR   92140
0146013665
MDR Report Key7027687
MDR Text Key113346155
Report Number1000165971-2017-00844
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 company representative,health
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial,Followup,Followup
Report Date 10/16/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/14/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2017
Device Model NumberREPLY CRT-P
Device Catalogue NumberREPLY CRT-P
Device Lot NumberS0191
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date10/16/2017
Event Location Hospital
Date Manufacturer Received01/24/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/31/2016
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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