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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SORIN CRM SYMPHONY; PULSE GENERATOR, PERMANENT, IMPLANTABLE
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SORIN CRM SYMPHONY; PULSE GENERATOR, PERMANENT, IMPLANTABLE Back to Search Results
Model Number SYMPHONY DR 2550
Device Problems Over-Sensing (1438); Pacing Problem (1439); Material Integrity Problem (2978)
Patient Problem No Information (3190)
Event Date 10/02/2019
Event Type  Injury  
Event Description
Reportedly, when the patient was in a horizontal position, reproducible noise oversensing was observed (date unknown) and a pause was observed on an ecg.It is unknown if the patient experienced symptoms because of the ventricular pacing inhibition.On (b)(6) 2019, the subject pacemaker was explanted due to battery depletion.The atrial and ventricular leads remained implanted and no additional lead was implanted even though it had been considered.As no reproducible noise oversensing occurred after the pacemaker replacement, the oversensing was suspected to be linked with the subject pacemaker.In addition, upon retrieval of the explanted pacemaker on (b)(6) 2019, it was observed that a part of the sealing of the pacemaker header was detached.
 
Event Description
Reportedly, when the patient was in a horizontal position, reproducible noise oversensing was observed (date unknown) and a pause was observed on an ecg.It is unknown if the patient experienced symptoms because of the ventricular pacing inhibition.On (b)(6) 2019, the subject pacemaker was explanted due to battery depletion.The atrial and ventricular leads remained implanted and no additional lead was implanted even though it had been considered.As no reproducible noise oversensing occurred after the pacemaker replacement, the oversensing was suspected to be linked with the subject pacemaker.In addition, upon retrieval of the explanted pacemaker on (b)(6) 2019, it was observed that a part of the sealing of the pacemaker header was detached.
 
Manufacturer Narrative
D3 (email address) corrected.F14 (email address) corrected.G1-2 (first name, last name, email address, phone number) corrected.Please refer to the attached analysis report.- attachment: [20200302 - file-2019-04158 - analysis_and_closure_report_resp-2020-00269.Pdf].
 
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Brand Name
SYMPHONY
Type of Device
PULSE GENERATOR, PERMANENT, IMPLANTABLE
Manufacturer (Section D)
SORIN CRM
parc d'affaires noveos 4 avenue réaumur
.
clamart 92140
FR  92140
MDR Report Key9403399
MDR Text Key168866978
Report Number1000165971-2019-00666
Device Sequence Number1
Product Code NVZ
Combination Product (y/n)N
PMA/PMN Number
P950029
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 03/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/03/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date02/09/2010
Device Model NumberSYMPHONY DR 2550
Device Catalogue NumberSYMPHONY DR 2550
Device Lot NumberS080805
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/23/2020
Was the Report Sent to FDA? No
Distributor Facility Aware Date10/03/2019
Event Location Hospital
Date Manufacturer Received02/17/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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