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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 Problem Battery Problem (2885)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/19/2017
Event Type  malfunction  
Event Description
Reportedly, on (b)(6) 2017, the device was interrogated during routine follow-up.Battery longevity was 48 months at beginning of session (battery impedance was 3.09 kohm and magnet rate was 95).No high outputs were programmed.Comparing to previous follow-ups, longevity was increased: 105 months on (b)(6) 2015, 32 months on (b)(6) 2015 and 24 months (battery impedance 2, 7 kohm and 96 magnet rate) on (b)(6) 2016.At the end of session longevity was 52 months.Preliminary analysis confirmed the reported event and based on available data showed normal battery depletion (as of (b)(6) 2017).
 
Manufacturer Narrative
Please refer to the attached analysis report.
 
Event Description
Reportedly, on (b)(6) 2017, the device was interrogated during routine follow-up.Battery longevity was 48 months at beginning of session (battery impedance was 3.09 kohm and magnet rate was 95).No high outputs were programmed.Comparing to previous follow-ups, longevity was increased: 105 months on (b)(6) 2015, 32 months on (b)(6) 2015 and 24 months (battery impedance 2, 7 kohm and 96 magnet rate) on (b)(6) 2016.At the end of session longevity was 52 months.Preliminary analysis confirmed the reported event and based on available data showed normal battery depletion (as of (b)(6) 2017).
 
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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
Manufacturer (Section G)
SORIN CRM 98, RUE MAURICE ARNOUX 92120 MONTROUGE FRANCE
parc d'affaires noveos 4 avenue réaumur
.
clamart 92140
FR   92140
Manufacturer Contact
elodie vincent
parc d'affaires noveos 4 avenue réaumur
.
clamart 92140
FR   92140
0146013665
MDR Report Key6700090
MDR Text Key79815637
Report Number1000165971-2017-00552
Device Sequence Number1
Product Code NVY
Combination Product (y/n)N
Reporter Country CodePO
PMA/PMN Number
P950029
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 06/19/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/11/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/17/2009
Device Model NumberSYMPHONY DR 2550
Device Catalogue NumberSYMPHONY DR 2550
Device Lot NumberS080131
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Distributor Facility Aware Date06/19/2017
Date Manufacturer Received11/21/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/17/2008
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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