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: ABBOTT MERLIN@HOME, RF TELEMETRY BASIC; PULSE GENERATOR, PERMANENT, IMPLANTABLE
  • 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
 

ABBOTT MERLIN@HOME, RF TELEMETRY BASIC; PULSE GENERATOR, PERMANENT, IMPLANTABLE Back to Search Results
Model Number EX1150
Device Problems Failure to Power Up (1476); Sparking (2595); Excessive Heating (4030)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/30/2024
Event Type  malfunction  
Event Description
It was reported that the programmer exhibited excessive heating, sparks, and then was unable to power on.The programmer was replaced.There was no reported user harm or any adverse consequences due to the reported spark.The patient was in stable condition.
 
Event Description
Additional information was received that sparks were not observed and instead there was a flash of light from the transmitter's led lights.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
MERLIN@HOME, RF TELEMETRY BASIC
Type of Device
PULSE GENERATOR, PERMANENT, IMPLANTABLE
Manufacturer (Section D)
ABBOTT
15900 valley view court
sylmar CA 91342
Manufacturer (Section G)
ABBOTT
15900 valley view court
sylmar CA 91342
Manufacturer Contact
richard williamson
15900 valley view court
sylmar, CA 91342
MDR Report Key18816792
MDR Text Key336664806
Report Number2017865-2024-33857
Device Sequence Number1
Product Code NVZ
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
P910023
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 03/08/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/01/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberEX1150
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received03/08/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-