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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. - CRM FACILITY ORCHESTRA PROGRAMMER, PACEMAKER

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SORIN GROUP ITALIA S.R.L. - CRM FACILITY ORCHESTRA PROGRAMMER, PACEMAKER Back to Search Results
Model Number ORCHESTRA PLUS
Device Problem Data Problem (3196)
Patient Problems Death (1802); Sudden Cardiac Death (2510); Sudden Cardiac Death (2510)
Event Date 10/02/2019
Event Type  Death  
Manufacturer Narrative

Return device analysis confirmed the reported behavior. An issue at the level of the filter board was also observed.

 
Event Description

Reportedly, on (b)(6) 2019, the patient suffered from a sudden cardiac death and external defibrillation shocks were applied by the intensive care unit to resuscitate the patient. The patient had not regained consciousness. The pacemaker was interrogated around 10:30 and one non-sustained v burst episode was recorded in the device memory. No warning message was displayed upon interrogation. On (b)(6) 2019, the pacemaker was interrogated and normal pacemaker operation was observed. The date of last statistics reset was (b)(6) 2019. However, no patient files dated (b)(6) 2019 or (b)(6) 2019 were available in the user session of the subject programmer. In administration mode, the sales representative could find expertise files dated (b)(6) 2019 and (b)(6) 2019, which were extracted manually as they were not visible in the file extraction tool. It was reported on (b)(6) 2019 that the patient passed away. Preliminary analysis revealed that the unavailable expertise files most probably resulted from a programmer hard disk issue. Based on available data, no evidence was found to suggest that the death was related to a device.

 
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Brand NameORCHESTRA
Type of DevicePROGRAMMER, PACEMAKER
Manufacturer (Section D)
SORIN GROUP ITALIA S.R.L. - CRM FACILITY
parc d'affaires noveos 4 avenue réaumur
.
clamart 92140
FR 92140
Manufacturer (Section G)
KONTRON SUDETENSTR. 8 87600 KAUFBEUREN GERMANY
parc d'affaires noveos 4 avenue réaumur
.
clamart 92140
FR 92140
Manufacturer Contact
laura ouaki
parc d'affaires noveos 4 avenue réaumur
.
clamart 92140
FR   92140
146013429
MDR Report Key9244592
MDR Text Key183187156
Report Number1000165971-2019-00601
Device Sequence Number1
Product Code KRG
Combination Product (Y/N)N
Reporter Country CodeFR
PMA/PMN NumberP980049
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/01/2020
1 Device Was Involved in the Event
2 PatientS WERE Involved in the Event:1 2 
Date FDA Received10/28/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberORCHESTRA PLUS
Device Catalogue NumberORCHESTRA PLUS
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/09/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date10/02/2019
Event Location No Information
Date Manufacturer Received03/12/2020
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 10/28/2019 Patient Sequence Number: 1
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