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 Problems Failure to Interrogate (1332); Pacemaker Found in Back-Up Mode (1440); Premature Elective Replacement Indicator (1483)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/19/2020
Event Type  Injury  
Event Description
Reportedly, during a follow-up performed on (b)(6) 2019, the battery impedance of the subject pacemaker was 4.31kohms and the estimated residual longevity was 27 months.During a follow-up performed on (b)(6) 2020, a message was displayed stating that the device was operating in standby mode and is was not possible to interrogate the subject pacemaker.
 
Event Description
Reportedly, during a follow-up performed on (b)(6) 2019, the battery impedance of the subject pacemaker was 4.31kohms and the estimated residual longevity was 27 months.During a follow-up performed on (b)(6) 2020, a message was displayed stating that the device was operating in standby mode and is was not possible to interrogate the subject pacemaker.
 
Manufacturer Narrative
Expertise of the returned device confirmed that it operated as specified.
 
Event Description
Reportedly, in january 2020, the estimated residual longevity displayed 32 months.During the follow-up performed on (b)(6) 2020, the estimated residual longevity displayed less than 5 months.The patient reported feeling sluggish and lethargic.A syncopal episode occurred approximately 1 week prior to the follow-up in november.The device replacement procedure is scheduled for (b)(6) 2020.Preliminary analysis results showed that based on available data, normal battery depletion occurred based on hrs guidelines.
 
Manufacturer Narrative
Preliminary analysis of the returned device revealed that electrical characteristics were within specifications.D6b and d9 updated.
 
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 Key10928621
MDR Text Key218984944
Report Number1000165971-2020-00777
Device Sequence Number1
Product Code DXY
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,Followup
Report Date 02/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/01/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date12/15/2008
Device Model NumberSYMPHONY DR 2550
Device Catalogue NumberSYMPHONY DR 2550
Device Lot NumberS070604
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/18/2020
Was the Report Sent to FDA? No
Distributor Facility Aware Date11/06/2020
Event Location Hospital
Date Manufacturer Received01/21/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
-
-