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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, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)

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SORIN GROUP ITALIA S.R.L. - CRM FACILITY REPLY PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P) Back to Search Results
Model Number REPLY CRT-P
Device Problem Battery Problem: Low Impedance (2973)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/24/2017
Event Type  malfunction  
Manufacturer Narrative
Refer attached report.
 
Event Description
Reportedly, at first interrogation before implantation the device showed a battery impedance of 4. 18 kohms. To ensure not to implant a device with low battery another device was used. It was reported also that the device was exposed to cold temperature before the interrogation in its commercial packaging.
 
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Brand NameREPLY
Type of DevicePULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)
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 Key6335923
MDR Text Key67932268
Report Number1000165971-2017-00120
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeSZ
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial
Report Date 01/24/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/16/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/02/2017
Device Model NumberREPLY CRT-P
Device Catalogue NumberREPLY CRT-P
Device Lot NumberS0113
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Distributor Facility Aware Date01/24/2017
Event Location Hospital
Date Manufacturer Received01/24/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/02/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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