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: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) MERLIN@HOME, RF TELEMETRY BASIC; PACEMAKER DATA TRANSMITTER
  • 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
 

ST. JUDE MEDICAL, INC.(CRM-SYLMAR) MERLIN@HOME, RF TELEMETRY BASIC; PACEMAKER DATA TRANSMITTER Back to Search Results
Model Number EX1150
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Information (3190)
Event Date 12/14/2017
Event Type  malfunction  
Manufacturer Narrative
No conclusion code available.Final analysis found burn marks on the ac power adapter and circuit board which caused the reported inability to power the transmitter.
 
Event Description
It was reported that the transmitter did not power on.No damage was noted to the prongs.The device was replaced.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
MERLIN@HOME, RF TELEMETRY BASIC
Type of Device
PACEMAKER DATA TRANSMITTER
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
15900 valley view court
sylmar CA 91342
Manufacturer (Section G)
ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
15900 valley view court
sylmar CA 91342
Manufacturer Contact
robert greenleaf
15900 valley view court
sylmar, CA 91342
8184932577
MDR Report Key7184766
MDR Text Key97060910
Report Number2017865-2018-00623
Device Sequence Number1
Product Code DRG
Combination Product (y/n)N
PMA/PMN Number
P030054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial
Report Date 01/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/11/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberEX1150
Device Catalogue NumberEX1150
Other Device ID Number05414734504799
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/03/2018
Date Manufacturer Received01/04/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/24/2010
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age77 YR
-
-