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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. - CRM FACILITY CPR3 PROGRAMMER, PACEMAKER

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SORIN GROUP ITALIA S.R.L. - CRM FACILITY CPR3 PROGRAMMER, PACEMAKER Back to Search Results
Model Number CPR3
Device Problem Interrogation Problem (4017)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/15/2020
Event Type  Malfunction  
Event Description

Reportedly, it was not possible to interrogate a pacemaker with the subject inductive telemetry head and the associated programmer. No green leds were lit when the programming head was placed over the implant. This pacemaker could be successfully interrogated with another programmer and another inductive telemetry head. Other pacemakers could successfully be interrogated with the subject inductive telemetry head and the associated programmer.

 
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Brand NameCPR3
Type of DevicePROGRAMMER, PACEMAKER
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)
EOLANE BLD J. BAPTISTE COLBERT 49520 COMBREE FRANCE
parc d'affaires noveos 4 avenue réaumur
.
clamart 92140
FR 92140
Manufacturer Contact
laura ouaki
parc d'affaires noveos 4 avenue réaumur
.
clamart 92140
FR   92140
146013429
MDR Report Key10258611
MDR Text Key198963277
Report Number1000165971-2020-00503
Device Sequence Number1
Product Code KRG
Combination Product (Y/N)N
Reporter Country CodeHK
PMA/PMN NumberP980049
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation BIOMEDICAL ENGINEER
Type of Report Initial,Followup,Followup
Report Date 09/18/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/10/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberCPR3
Device Catalogue NumberCPR3
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date06/15/2020
Event Location No Information
Date Manufacturer Received09/02/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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