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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. - CRM FACILITY PARADYM; DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
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SORIN GROUP ITALIA S.R.L. - CRM FACILITY PARADYM; DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER Back to Search Results
Model Number PARADYM VR 8250
Device Problems Defibrillation/Stimulation Problem (1573); Incorrect Or Inadequate Test Results (2456); Issue With Displayed Error Message (2967)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/10/2014
Event Type  Injury  
Event Description
A warning message was displayed indicating that the defibrillation system would be ineffective.Vf was detected on (b)(6) 2014 but no shock therapy could be delivered by the defibrillation system due to low shock impedance (overload).The vf arrhythmia spontaneously ended.The defibrillation lead impedance and coils continuities were within the normal range.
 
Event Description
A warning message was displayed indicating that the defibrillation system would be ineffective.Vf was detected on (b)(6) 2014 but no shock therapy could be delivered by the defibrillation system due to low shock impedance (overload).The vf arrhythmia spontaneously ended.The defibrillation lead impedance and coils continuities were within the normal range.
 
Manufacturer Narrative
Physician reported on (b)(6) 2015 that at scheduled follow-up on (b)(6) 2015, a warning message stating ¿low shock impedance¿ was displayed¿.However, the lead was already replaced on (b)(6) 2014 due to low shock impedance.In addition, it was not possible to perform a charge time test on (b)(6) 2015.Further analysis was performed for the subject device.Please refer to the attached analysis report for complete details.
 
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Brand Name
PARADYM
Type of Device
DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
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)
SORIN GROUP ITALIA SRL VIA CRESCENTINO 13040 SALUGGIA ITALY
parc d'affaires noveos 4 avenue réaumur
.
clamart 9214 0
FR   92140
Manufacturer Contact
elodie vincent
parc d'affaires noveos 4 avenue réaumur
.
clamart 92140
FR   92140
0146013665
MDR Report Key4247637
MDR Text Key5018357
Report Number1000165971-2014-00622
Device Sequence Number1
Product Code MRM
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
PP980049
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 11/10/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/13/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date06/16/2012
Device Model NumberPARADYM VR 8250
Device Catalogue NumberPARADYM VR 8250
Device Lot Number2533
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Distributor Facility Aware Date11/10/2014
Event Location Outpatient Diagnostic Facility
Date Manufacturer Received06/16/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/16/2011
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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