MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) MERLIN@HOME, RF TELEMETRY BASIC; PACEMAKER DATA TRANSMITTER

Model Number EX1150

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/11/2017

Event Type  malfunction  

Manufacturer Narrative

Analysis was normal.No anomalies were found.The reported field event of the transmitter sending a shock to the patient through his implant was not verified as the event could not be reproduced.A merlin@home transmitter does not have the capabilities to instruct/program a device: it is a diagnostic device that monitors sjm implantable cardiac device and transmits device data to merlin.Net.

Event Description

It was reported that the patient felt shocks that comes from the transmitter.The shock happens whenever the patient lay down.The patient reported that this event has been going on for 6 months.No further information is available.

• Brand Name: MERLIN@HOME, RF TELEMETRY BASIC
• Type of Device: PACEMAKER DATA TRANSMITTER
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 6936327
• MDR Text Key: 89864193
• Report Number: 2017865-2017-32502
• Device Sequence Number: 1
• Product Code: DRG
• Combination Product (y/n): N
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 06/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EX1150
• Other Device ID Number: 05414734504799
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 78 YR