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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SORIN CRM S.A.S SYMPHONY; PULSE GENERATOR, PERMANENT, IMPLANTABLE
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SORIN CRM S.A.S SYMPHONY; PULSE GENERATOR, PERMANENT, IMPLANTABLE Back to Search Results
Model Number RHAPSODY + DR 2530
Device Problem Premature Elective Replacement Indicator (1483)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/02/2020
Event Type  Injury  
Event Description
Reportedly, premature battery depletion occurred compared to the estimated residual longevity displayed by the programmer (on (b)(6) 2018 it was 46 months, on (b)(6) 2019 it was 30 months and on (b)(6) 2020 it was 5 months).
 
Manufacturer Narrative
Please refer to the attached analysis report.
 
Event Description
Reportedly, premature battery depletion occurred compared to the estimated residual longevity displayed by the programmer (on (b)(6) 2018 it was 46 months, on (b)(6) 2019 it was 30 months and on (b)(6) 2020 it was 5 months).
 
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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 Key11314207
MDR Text Key231386824
Report Number1000165971-2021-00276
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 company representative,health
Type of Report Initial,Followup
Report Date 05/20/2021
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 Date01/30/2006
Device Model NumberRHAPSODY + DR 2530
Device Catalogue NumberRHAPSODY + DR 2530
Device Lot NumberM040709
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date01/20/2021
Event Location Hospital
Initial Date Manufacturer Received 01/20/2021
Initial Date FDA Received02/11/2021
Supplement Dates Manufacturer Received04/27/2021
Supplement Dates FDA Received05/20/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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