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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 Premature Elective Replacement Indicator (1483)
Patient Problem Bradycardia (1751)
Event Date 06/18/2020
Event Type  malfunction  
Event Description
Reportedly, the pacing system was implanted on (b)(6) 2012.On (b)(6) 2020, during a follow-up, the recommended replacement time (rrt) had not been reached yet.On (b)(6) 2020, the patient went to the hospital with a low cardiac rate (35 bpm).The rrt was reached with a battery impedance above 10kohms.The pacemaker was explanted on the same day and returned for analysis.Preliminary analysis results showed that based on available data, normal battery depletion occurred based on hrs guidelines.Electrical characteristics of the returned device were within specifications.
 
Event Description
Reportedly, the pacing system was implanted on (b)(6) 2012.On (b)(6) 2020, during a follow-up, the recommended replacement time (rrt) had not been reached yet.On (b)(6) 2020, the patient went to the hospital with a low cardiac rate (35 bpm).The rrt was reached with a battery impedance above 10kohms.The pacemaker was explanted on the same day and returned for analysis.Preliminary analysis results showed that based on available data, normal battery depletion occurred based on hrs guidelines.Electrical characteristics of the returned device were within specifications.
 
Manufacturer Narrative
Please refer to the attached analysis report.
 
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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
MDR Report Key10285911
MDR Text Key199735822
Report Number1000165971-2020-00506
Device Sequence Number1
Product Code LWP
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 11/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/16/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/28/2013
Device Model NumberREPLY 200 DR
Device Catalogue NumberREPLY 200 DR
Device Lot Number2590
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/01/2020
Was the Report Sent to FDA? No
Distributor Facility Aware Date06/22/2020
Event Location Hospital
Date Manufacturer Received10/14/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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