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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. - CRM FACILITY REPLY; PULSE GENERATOR, PERMANENT, IMPLANTABLE
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SORIN GROUP ITALIA S.R.L. - CRM FACILITY REPLY; PULSE GENERATOR, PERMANENT, IMPLANTABLE Back to Search Results
Model Number REPLY DR
Device Problem Failure to Interrogate (1332)
Patient Problem Electric Shock (2554)
Event Date 11/14/2017
Event Type  Injury  
Event Description
On (b)(6) 2017, the patient received 3 external shocks at 200 joules due to a ventricular fibrillation.On (b)(6) 2017, during a routine follow-up, the subject device could reportedly not be interrogated.The device was replaced on (b)(6) 2017.
 
Event Description
On (b)(6) 2017, the patient received 3 external shocks at 200 joules due to a ventricular fibrillation.On (b)(6) 2017, during a routine follow-up, the subject device could reportedly not be interrogated.The device was replaced on (b)(6) 2017.
 
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Brand Name
REPLY
Type of Device
PULSE GENERATOR, PERMANENT, IMPLANTABLE
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 92140
FR   92140
Manufacturer Contact
elodie vincent
parc d'affaires noveos 4 avenue réaumur
.
clamart 92140
FR   92140
0146013665
MDR Report Key7192815
MDR Text Key97321929
Report Number1000165971-2018-00042
Device Sequence Number1
Product Code NVZ
Combination Product (y/n)N
Reporter Country CodeBE
PMA/PMN Number
P950029
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Nursing Assistant
Type of Report Initial,Followup
Report Date 12/24/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Device Operator Health Professional
Device Expiration Date07/14/2014
Device Model NumberREPLY DR
Device Catalogue NumberREPLY DR
Device Lot Number2673
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/11/2018
Is the Reporter a Health Professional? Yes
Distributor Facility Aware Date12/24/2017
Event Location Home
Initial Date Manufacturer Received 12/24/2017
Initial Date FDA Received01/16/2018
Supplement Dates Manufacturer Received01/16/2018
Supplement Dates FDA Received02/05/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/14/2012
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) Life Threatening; Required Intervention;
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