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

Model Number EX1150

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Pain (1994); Shock from Patient Lead(s) (3162)

Event Date 11/09/2015

Event Type  Injury  

Event Description

It was reported that the patient complained of feeling shocks and pain while napping or sleeping in the device pocket and suspected his transmitter could cause these shocks.The patient received another transmitter and cell adapter.Upon investigation, the device connections looked good and no vt or shocks had been delivered from the device.These shocks could be from the device, the icd maybe pinching a nerve or pocket being formed around the device, which often seen during the healing process.The patient was paced at high outputs and he felt nothing or shocks during this test.

Manufacturer Narrative

Final analysis found normal device characteristics.

• Brand Name: MERLIN HOME TRANSMITTER
• Type of Device: PACEMAKER DATA TRANSMITTER
• 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: jaime chavez ; 15900 valley view court; sylmar, CA 91342 ; 8184934022
• MDR Report Key: 5350875
• MDR Text Key: 35254255
• Report Number: 2017865-2016-00080
• 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: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/10/2017

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: Lay User/Patient
• Device Model Number: EX1150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/10/2015
• Initial Date FDA Received: 01/07/2016
• Supplement Dates Manufacturer Received: 11/10/2015
• Supplement Dates FDA Received: 11/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: CD1357-40Q, (B)(4)
• Patient Outcome(s): Other
• Patient Age: 71 YR