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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 200; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
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SORIN GROUP ITALIA S.R.L. - CRM FACILITY REPLY 200; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) Back to Search Results
Model Number REPLY 200 DR
Device Problem Pacing Intermittently (1443)
Patient Problem Syncope (1610)
Event Date 09/29/2016
Event Type  malfunction  
Event Description
Reportedly, the device was found to be in unipolar 2 hours after implant, and was unable to be programmed back to bipolar ( bipolar lead) the patient subsequently suffered intermittent loss of consciousness and was documented to be having long pauses and periods of non capture.The device was not kept implanted and will be returned for analysis.
 
Manufacturer Narrative
Preliminary analysis of the returned device confirmed that electrical and mechanical characteristics were within specifications.
 
Event Description
Reportedly, the device was found to be in unipolar 2 hours after implant, and was unable to be programmed back to bipolar ( bipolar lead) the patient subsequently suffered intermittent loss of consciousness and was documented to be having long pauses and periods of non capture.The device was not kept implanted and will be returned for analysis.
 
Event Description
Reportedly, the device was found to be in unipolar 2 hours after implant, and was unable to be programmed back to bipolar (bipolar lead) the patient subsequently suffered intermittent loss of consciousness and was documented to be having long pauses and periods of non capture.The device was not kept implanted and will be returned for analysis.
 
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Brand Name
REPLY 200
Type of Device
IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
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 Key6050431
MDR Text Key58194472
Report Number1000165971-2016-00653
Device Sequence Number1
Product Code DTB
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Health Professional
Type of Report Initial,Followup,Followup
Report Date 10/03/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/24/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/13/2018
Device Model NumberREPLY 200 DR
Device Catalogue NumberREPLY 200 DR
Device Lot NumberS0193
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/05/2016
Is the Reporter a Health Professional? Yes
Distributor Facility Aware Date10/03/2016
Date Manufacturer Received04/03/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/13/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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