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

Model Number EX1150

Device Problem Communication or Transmission Problem (2896)

Patient Problem Death (1802)

Event Date 11/07/2018

Event Type  Death  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

It was reported a ventricular fibrillation (vf) episode with therapy from (b)(6) 2018 failed to transmit via merlin.Net until (b)(6) 2018 at 1:40 am.Patient had additional vf episodes during the day of (b)(6) and passed away.Physician alleges that if device would have appropriately notified the clinic of the initial vf episode then they could have intervened and possible prevented patient¿s death.It is unclear if the delayed transmission was due to an issue with the device or transmitter.No further information available at this time.

Event Description

New information received notes the transmitter did not read the patient at the time patient experienced the symptoms for the alert to be posted.

Manufacturer Narrative

The field complaint that the transmitter did not function as intended by not sending the transmissions to merlin.Net on time was not verified as the event could not be reproduced.Device was tested and no anomalies were found.

• Type of Device: PACEMAKER DATA TRANSMITTER
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• Manufacturer Contact: robert greenleaf ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 8118333
• MDR Text Key: 128852542
• Report Number: 2938836-2018-12595
• 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: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 03/19/2019

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: EX1150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/14/2018
• Initial Date FDA Received: 11/29/2018
• Supplement Dates Manufacturer Received: 02/21/2019; 03/11/2019
• Supplement Dates FDA Received: 03/07/2019; 03/19/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/29/2015
• 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 Outcome(s): Death
• Patient Age: 64 YR