Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. - CRM FACILITY ORCHESTRA; PROGRAMMER, PACEMAKER
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SORIN GROUP ITALIA S.R.L. - CRM FACILITY ORCHESTRA; PROGRAMMER, PACEMAKER Back to Search Results
Model Number ORCHESTRA PLUS
Device Problem Wireless Communication Problem (3283)
Patient Problem No Information (3190)
Event Date 10/16/2019
Event Type  malfunction  
Event Description
Reportedly, intermittent loss of rf communication was encountered on (b)(6) 2019 with the subject programmer.Preliminary analysis revealed that the observed behavior could have resulted from a hardware issue at the level of the programmer.
 
Manufacturer Narrative
Please refer to the attached analysis report.- attachment: [20200310 - file-2020-00272 - analysis_and_closure_report_resp-2020-00179.Pdf].
 
Event Description
Reportedly, intermittent loss of rf communication was encountered on (b)(6) 2019 with the subject programmer.Preliminary analysis revealed that the observed behavior could have resulted from a hardware issue at the level of the programmer.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ORCHESTRA
Type of Device
PROGRAMMER, PACEMAKER
Manufacturer (Section D)
SORIN GROUP ITALIA S.R.L. - CRM FACILITY
parc d'affaires noveos 4 avenue réaumur
.
clamart 92140
FR  92140
MDR Report Key9733258
MDR Text Key183901830
Report Number1000165971-2020-00269
Device Sequence Number1
Product Code KRG
Combination Product (y/n)N
PMA/PMN Number
P980049
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 04/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/20/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberORCHESTRA PLUS
Device Catalogue NumberORCHESTRA PLUS
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date01/28/2020
Date Manufacturer Received03/10/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-