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

Model Number EX1100

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 12/23/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that through merlin.Net transmission, an unexpected decrease in device longevity was observed.On (b)(6) 2015 remote transmission, battery longevity was 3.7-3.9 years.On another transmission on (b)(6) 2016, estimated longevity was 2.0 years.St.Jude medical technical representative performed in-house calculations and explained that the device over-estimated the longevity in (b)(6) 2015.It was closer to 2.0-2.75 years in (b)(6) 2015.Now, the programmer displayed estimate of 1.3 years remaining to eri and it should be accurate from this point onward.The patient will continue to be followed normally.

Manufacturer Narrative

Manufacturing report 2938836-2016-14094 should not have been reported as a medical device report (mdr).Please retract the mdr.This event is reportable on programmer.

Manufacturer Narrative

Follow-up number 2 of manufacturing report 2938836-2016-14094 should not have been reported as a medical device report (mdr) as the initial was retracted.

• Brand Name: MERLIN@HOME INDUCTIVE VERSION
• Type of Device: PACEMAKER DATA TRANSMITTER
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 6097017
• MDR Text Key: 59737399
• Report Number: 2938836-2016-14094
• Device Sequence Number: 1
• Product Code: DRG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EX1100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/27/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 74 YR