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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. - CRM FACILITY PLATINIUM; DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
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SORIN GROUP ITALIA S.R.L. - CRM FACILITY PLATINIUM; DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER Back to Search Results
Model Number PLATINIUM DR 1510
Device Problem Unable to Obtain Readings (1516)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/15/2018
Event Type  malfunction  
Event Description
The physician reported that recorded episodes could not be displayed during the interrogation session, but could be displayed later by opening the patient file from the manager.An interrogation on a 2nd programmer did not change the situation.
 
Manufacturer Narrative
(b)(4).
 
Event Description
The physician reported that recorded episodes could not be displayed during the interrogation session, but could be displayed later by opening the patient file from the manager.An interrogation on a 2nd programmer did not change the situation.
 
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Brand Name
PLATINIUM
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 Key7240062
MDR Text Key99102476
Report Number1000165971-2018-00143
Device Sequence Number1
Product Code MRM
UDI-Device Identifier08031527014364
UDI-Public(01)08031527014364(11)160219(17)170919
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
Type of Report Initial,Followup
Report Date 01/17/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/04/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/19/2017
Device Model NumberPLATINIUM DR 1510
Device Catalogue NumberPLATINIUM DR 1510
Device Lot NumberS0151
Was Device Available for Evaluation? No
Distributor Facility Aware Date01/17/2018
Date Manufacturer Received03/16/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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