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

Model Number 3650

Device Problem Incorrect Measurement (1383)

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

Event Date 10/23/2017

Event Type  malfunction  

Event Description

It was reported that an over estimation of battery longevity was displayed during device interrogation.Overprojection of the battery curve during the midlife was suspected to be cause for the variation in longevity.No intervention was performed at the time.Monitoring will continue with monthly follow ups until device reaches eri.

• Brand Name: MERLIN PROGRAMMER
• Type of Device: PACEMAKER PROGRAMMER
• 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 Key: 7150087
• MDR Text Key: 95927390
• Report Number: 2017865-2017-36708
• Device Sequence Number: 1
• Product Code: KRG
• 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: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3650
• Device Catalogue Number: 3650
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/31/2017
• 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 Number: 1
• Patient Age: 63 YR