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U.S. Department of Health and Human Services

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

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ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) PACEMAKER DATA TRANSMITTER Back to Search Results
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.
 
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Type of DevicePACEMAKER 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 Key8118333
MDR Text Key128852542
Report Number2938836-2018-12595
Device Sequence Number1
Product Code DRG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P030054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
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
Date FDA Received11/29/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberEX1150
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/18/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/11/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/29/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/29/2018 Patient Sequence Number: 1
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