• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ZEPHYR XL DR IMPLANTABLE PACEMAKER PULSE GENERATOR

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ZEPHYR XL DR IMPLANTABLE PACEMAKER PULSE GENERATOR Back to Search Results
Model Number 5826
Device Problem Premature Discharge of Battery (1057)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/15/2019
Event Type  Injury  
Event Description
During a follow-up in clinic, the device was noted to be at elective replacement indicator (eri) much sooner than expected. Premature battery depletion was alleged. The device was explanted and replaced and the patient was stable with no consequences. Additional information has been requested, but not yet received.
 
Manufacturer Narrative
Upon receipt, the device was interrogated, and communication was successfully established. The device image indicated that autocapture feature was enabled and device was operated in high output mode at times. When automatic settings are programmed, such as autocapture, the device output would adjust itself to accommodate the patient¿s needs for pacing and thus affect the estimated longevity of the device. Analysis performed, including mechanical stressing of the device and functional testing, did not find any anomalies. A longevity assessment was performed using field settings and device had normal battery depletion with the appropriate remaining longevity. The reported event of premature battery depletion was not confirmed.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameZEPHYR XL DR
Type of DeviceIMPLANTABLE PACEMAKER PULSE GENERATOR
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
elizabeth boltz
15900 valley view court
sylmar, CA 91342
8184932577
MDR Report Key8291629
MDR Text Key134562481
Report Number2017865-2019-01464
Device Sequence Number1
Product Code LWP
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
P880086
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/21/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/31/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/29/2012
Device Model Number5826
Device Lot Number3198755
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/29/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/07/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/26/2010
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: 01/31/2019 Patient Sequence Number: 1
-
-