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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 Impedance Issue (2884)
Patient Problem No Information (3190)
Event Date 01/22/2018
Event Type  Injury  
Event Description
Reportedly, during the last follow-up performed on (b)(6) 2018, the pacemaker had reached end of life, whereas during the previous follow-up performed six months earlier, the battery impedance was still 1 kohm.The pacemaker was replaced and returned for analysis.Preliminary analysis showed that, based on available data, normal battery depletion occurred (based on hrs guidelines).
 
Manufacturer Narrative
Preliminary analysis of the returned device confirmed that electrical characteristics were within specifications.
 
Event Description
Reportedly, during the last follow-up performed on 22 january 2018, the pacemaker had reached end of life, whereas during the previous follow-up performed six months earlier, the battery impedance was still 1 kohm.The pacemaker was replaced and returned for analysis.Preliminary analysis showed that, based on available data, normal battery depletion occurred (based on hrs guidelines).
 
Event Description
Reportedly, during the last follow-up performed on (b)(6) 2018, the pacemaker had reached end of life, whereas during the previous follow-up performed six months earlier, the battery impedance was still 1 kohm.The pacemaker was replaced and returned for analysis.Preliminary analysis showed that, based on available data, normal battery depletion occurred (based on hrs guidelines).
 
Manufacturer Narrative
(b)(4).
 
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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 Key7348133
MDR Text Key102713362
Report Number1000165971-2018-00275
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,Followup
Report Date 05/16/2018
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 Physician
Device Expiration Date03/06/2009
Device Model NumberSYMPHONY DR 2550
Device Catalogue NumberSYMPHONY DR 2550
Device Lot NumberS070823
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/16/2018
Distributor Facility Aware Date02/28/2018
Event Location Hospital
Initial Date Manufacturer Received 02/28/2018
Initial Date FDA Received03/19/2018
Supplement Dates Manufacturer Received04/18/2018
04/27/2018
Supplement Dates FDA Received04/25/2018
05/16/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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