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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. - CRM FACILITY ISOLINE; DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
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SORIN GROUP ITALIA S.R.L. - CRM FACILITY ISOLINE; DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER Back to Search Results
Model Number ISOLINE 2CR6
Device Problem Fracture (1260)
Patient Problem No Information (3190)
Event Date 09/20/2018
Event Type  Injury  
Event Description
The hospital requested analysis of an x-ray, which had been taken from the patient implanted with the subject lead.The physician suspects the possibility of conductor fracture of the svc coil of the icd lead although there were no abnormal findings in the patient data.
 
Manufacturer Narrative
Preliminary analysis did not reveal any irregularity.
 
Event Description
Reportedly, a conductor fracture of the svc coil of the subject lead is suspected although no anomalies were observed in the patient data.It should be noted that the associated icd has been explanted as the eri (elective replacement indicator) was detected.
 
Manufacturer Narrative
Please refer to the analysis report.
 
Event Description
Reportedly, a conductor fracture of the svc coil of the subject lead is suspected although no anomalies were observed in the patient data.It should be noted that the associated icd has been explanted as the eri (elective replacement indicator) was detected.
 
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Brand Name
ISOLINE
Type of Device
DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
Manufacturer (Section D)
SORIN GROUP ITALIA S.R.L. - CRM FACILITY
via crescentino s.n.
.
saluggia 13040
IT  13040
MDR Report Key7913526
MDR Text Key121852715
Report Number1000165971-2018-00871
Device Sequence Number1
Product Code MRM
Combination Product (y/n)N
PMA/PMN Number
P980049
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Remedial Action Recall
Type of Report Initial,Followup,Followup
Report Date 12/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/27/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date05/06/2011
Device Model NumberISOLINE 2CR6
Device Catalogue NumberISOLINE 2CR6
Device Lot Number2368
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date09/25/2018
Event Location Hospital
Date Manufacturer Received12/04/2018
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberZ-0928-2013
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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