• 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
Device Problems Display Difficult to Read (1181); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/26/2018
Event Type  malfunction  
Event Description
Reportedly, the problem with the programmer is the display screen displays abnormal colors and/or lines making the display difficult or impossible to read.
 
Manufacturer Narrative
Preliminary analysis of the returned programmer confirmed the reported event; some screws were missing on the screen, leading to the reported display issue.
 
Event Description
Reportedly, the problem with the programmer is the display screen displays abnormal colors and/or lines making the display difficult or impossible to read.
 
Manufacturer Narrative
Please refer to the attached analysis report.
 
Event Description
Reportedly, the problem with the programmer is the display screen displays abnormal colors and/or lines making the display difficult or impossible to read.
 
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 Key7442429
MDR Text Key105918867
Report Number1000165971-2018-00388
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,Followup
Report Date 08/08/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberORCHESTRA
Device Catalogue NumberORCHESTRA
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/12/2018
Was the Report Sent to FDA? No
Distributor Facility Aware Date03/26/2018
Initial Date Manufacturer Received 03/26/2018
Initial Date FDA Received04/19/2018
Supplement Dates Manufacturer Received06/07/2018
07/31/2018
Supplement Dates FDA Received06/25/2018
08/08/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-