Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SORIN CRM S.A.S SYMPHONY; PULSE GENERATOR, PERMANENT, IMPLANTABLE
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SORIN CRM S.A.S SYMPHONY; PULSE GENERATOR, PERMANENT, IMPLANTABLE Back to Search Results
Model Number SYMPHONY DR 2550
Device Problem Premature Discharge of Battery (1057)
Patient Problem No Information (3190)
Event Date 12/03/2020
Event Type  Injury  
Event Description
The pacing system was implanted on (b)(6) 2006.Reportedly, during a follow-up performed on (b)(6) 2019, the battery impedance was 4.25 kohms and the estimated residual longevity was 33 months.The atrial output was 2.0 v / 0.35 ms for a threshold of 1.0 v / 0.35 ms, the atrial sensitivity was programmed at 0.8 mv and the atrial sensing was measured at 0.8 mv.The atrial lead impedance was measured at 473 ohms.The ventricular output was 2.5v / 0.35 ms in auto for a threshold of 0.75 v / 0.35 ms, the ventricular sensitivity was programmed at 2.7 mv.The ventricular lead impedance was measured at 488 ohms.The next follow-up was scheduled for one year and a half later.During the follow-up performed on (b)(6) 2020, the subject pacemaker was found to have reached its recommended replacement time (rrt) with a battery impedance of 34.83 kohms.The pacemaker was pacing at 70 min-1, with an output of 5.0 v / 0.5 ms.On (b)(6) 2020, the pacing mode changed to ddd during the interrogation.The pacemaker was explanted and should be returned for expertise.Preliminary analysis revealed that, based on the provided patient files, normal battery depletion occurred (according to hrs guidelines).
 
Event Description
The pacing system was implanted on (b)(6) 2006.Reportedly, during a follow-up performed on (b)(6) 2019, the battery impedance was 4.25 kohms and the estimated residual longevity was 33 months.The atrial output was 2.0 v / 0.35 ms for a threshold of 1.0 v / 0.35 ms, the atrial sensitivity was programmed at 0.8 mv and the atrial sensing was measured at 0.8 mv.The atrial lead impedance was measured at 473 ohms.The ventricular output was 2.5v / 0.35 ms in auto for a threshold of 0.75 v / 0.35 ms, the ventricular sensitivity was programmed at 2.7 mv.The ventricular lead impedance was measured at 488 ohms.The next follow-up was scheduled for one year and a half later.During the follow-up performed on (b)(6) 2020, the subject pacemaker was found to have reached its recommended replacement time (rrt) with a battery impedance of 34.83 kohms.The pacemaker was pacing at 70 min-1, with an output of 5.0 v / 0.5 ms.On (b)(6) 2020, the pacing mode changed to ddd during the interrogation.The pacemaker was explanted and should be returned for expertise.Preliminary analysis revealed that, based on the provided patient files, normal battery depletion occurred (according to hrs guidelines).
 
Manufacturer Narrative
Please refer to the attached analysis report.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SYMPHONY
Type of Device
PULSE GENERATOR, PERMANENT, IMPLANTABLE
Manufacturer (Section D)
SORIN CRM S.A.S
98 rue maurice arnoux
.
montrouge 92120
FR  92120
MDR Report Key11046981
MDR Text Key241254780
Report Number1000165971-2020-00830
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 01/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date05/24/2008
Device Model NumberSYMPHONY DR 2550
Device Catalogue NumberSYMPHONY DR 2550
Device Lot NumberS061110
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/06/2021
Was the Report Sent to FDA? No
Distributor Facility Aware Date12/03/2020
Event Location Hospital
Initial Date Manufacturer Received 12/03/2020
Initial Date FDA Received12/21/2020
Supplement Dates Manufacturer Received01/12/2021
Supplement Dates FDA Received01/26/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
-
-