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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 RF; DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
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SORIN GROUP ITALIA S.R.L. - CRM FACILITY PARADYM RF; DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER Back to Search Results
Model Number PARADYM RF VR 9250
Device Problem Wireless Communication Problem (3283)
Patient Problem No Information (3190)
Event Date 10/23/2019
Event Type  malfunction  
Event Description
Reportedly, during a follow up performed on (b)(6) 2019, the following message was displayed: ''[65] technical issue.Rf has been automatically deactivated due to external activations on (b)(6) 2018.Please reactivate it if needed.'' preliminary analysis showed that the rf was deactivated due to too many unsuccessful rf communication attempts that occurred on (b)(6) 2018.The device behaved as specified.
 
Event Description
Reportedly, during a follow up performed on (b)(6) 2019, the following message was displayed: ''[65] technical issue.Rf has been automatically deactivated due to external activations on (b)(6) 2018.Please reactivate it if needed.'' preliminary analysis showed that the rf was deactivated due to too many unsuccessful rf communication attempts that occurred on (b)(6) 2018.The device behaved as specified.
 
Manufacturer Narrative
D3 (email address) corrected f14 (email address) corrected g1-2 (first name, last name, email address, phone number) corrected please refer to the attached analysis report.
 
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Brand Name
PARADYM RF
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
MDR Report Key9321477
MDR Text Key174188872
Report Number1000165971-2019-00633
Device Sequence Number1
Product Code MRM
Combination Product (y/n)N
PMA/PMN Number
P060027
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 02/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/14/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/12/2013
Device Model NumberPARADYM RF VR 9250
Device Catalogue NumberPARADYM RF VR 9250
Device Lot Number2634
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date10/24/2019
Event Location Hospital
Date Manufacturer Received01/16/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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