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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. REPLY
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SORIN GROUP ITALIA S.R.L. REPLY Back to Search Results
Model Number REPLY DR
Device Problem Premature End-of-Life Indicator (1480)
Patient Problem Dizziness (2194)
Event Date 01/09/2014
Event Type  Injury  
Event Description
Reportedly, a patient follow up was performed on (b)(6) 2014 due to dizziness, the subject pacemaker was interrogated and found in back up mode vvi 70min-1 with a battery impedance of 10.24 kohm.The physician considered the battery of the pacemaker was prematurely discharged (recommended replacement time reached to early).The device was explanted and is returned for analysis.
 
Manufacturer Narrative
This event concerns a device that was manufactured and used outside the united states.Analysis is pending.
 
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Brand Name
REPLY
Manufacturer (Section D)
SORIN GROUP ITALIA S.R.L.
saluggia
IT 
Manufacturer (Section G)
SORIN GROUP ITALIA S.R.L.
via crescentino s.n.
saluggia (vc) 1304 0
IT   13040
Manufacturer Contact
e vincent
4 avenue reaumur
clamart cedex 92140
FR   92140
46013687
MDR Report Key3644762
MDR Text Key18874217
Report Number1000165971-2014-00043
Device Sequence Number1
Product Code NVZ
Combination Product (y/n)N
Reporter Country CodeAU
PMA/PMN Number
P950029
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 01/09/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/31/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date02/03/2009
Device Model NumberREPLY DR
Device Catalogue NumberREPLY DR
Device Lot Number2227
Was Device Available for Evaluation? No
Date Returned to Manufacturer01/23/2014
Is the Reporter a Health Professional? Yes
Event Location Hospital
Date Manufacturer Received01/09/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured07/01/2007
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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