MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) MERLIN PROGRAMMER; PROGRAMMER, PACEMAKER

Model Number 3650

Device Problems Failure to Interrogate (1332); Failure to Power Up (1476); Data Problem (3196)

Patient Problem Death (1802)

Event Date 10/21/2020

Event Type  Death  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

It was reported that during implant procedure, the programmer did not recognize the device.The physician believed that the failure of the programmer put the patient at serious risk.Error message and failure to power up issues were also noted.A new programmer was used after an hour and successfully connected.The patient expired one day after the implant procedure.

Manufacturer Narrative

Additional information: d10.The field complaint that the programmer is not turning on properly was confirmed.During analysis, the unit would display an "error 10" message shortly after boot up.Inspection of the dtm board revealed, detached solder joints on j9 as the cause of the complaint.

• Brand Name: MERLIN PROGRAMMER
• Type of Device: PROGRAMMER, PACEMAKER
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• MDR Report Key: 10813981
• MDR Text Key: 215455658
• Report Number: 2938836-2020-09186
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734500661
• UDI-Public: 05414734500661
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 01/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3650
• Device Catalogue Number: 3650
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/21/2020
• Initial Date FDA Received: 11/09/2020
• Supplement Dates Manufacturer Received: 12/11/2020
• Supplement Dates FDA Received: 01/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death