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 ORCHESTRA PLUS LINK; UNKNOWN
  • 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 ORCHESTRA PLUS LINK; UNKNOWN Back to Search Results
Model Number ORCHESTRA PLUS LINK
Device Problem Wireless Communication Problem (3283)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/11/2018
Event Type  malfunction  
Event Description
It was reported that loss of rf communication occured inside the operating room during implantation.When the telemetry is lost it is impossible to recover it and prolonged the procedure; whatever the defibrillator, the distance between the defibrillator and the programmer, the programmer or the trolley used.It was observed that regular rf communication was observed outside of the operating room.
 
Manufacturer Narrative
Please refer to the attached investigation report.
 
Event Description
It was reported that loss of rf communication occured inside the operating room during implantation.When the telemetry is lost it is impossible to recover it and prolonged the procedure; whatever the defibrillator, the distance between the defibrillator and the programmer, the programmer or the trolley used.It was observed that regular rf communication was observed outside of the operating room.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ORCHESTRA PLUS LINK
Type of Device
UNKNOWN
Manufacturer (Section D)
SORIN GROUP ITALIA S.R.L - CRM
parc d'affaires noveos 4 avenue réaumur
.
clamart 92140
FR  92140
MDR Report Key7344335
MDR Text Key102748786
Report Number1000165971-2018-00262
Device Sequence Number1
Product Code MRM
Combination Product (y/n)N
PMA/PMN Number
P980049
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 12/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/16/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberORCHESTRA PLUS LINK
Device Catalogue NumberORCHESTRA PLUS LINK
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date01/11/2018
Event Location Hospital
Date Manufacturer Received12/20/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-