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

Model Number EX1150

Device Problem Wireless Communication Problem (3283)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 09/12/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the device was not transmitting through the remote transmission.The patient was not feeling well and presented in the emergency room.The device delivered alerts for ventricular tachycardia and ventricular fibrillation episodes and they were successfully treated with atp and hv therapy.The patient was discharged and was doing fine after the event.

• Type of Device: PACEMAKER DATA TRANSMITTER
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: jaime chavez ; 645 almanor avenue; sunnyvale, CA 94085 ; 8184934022
• MDR Report Key: 6032716
• MDR Text Key: 57551085
• Report Number: 2938836-2016-12799
• 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,consum
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 09/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EX1150
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/12/2016
• 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
• Treatment: CD1411-36Q, 7137098
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 68 YR