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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102; GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 102; GENERATOR Back to Search Results
Model Number 102
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Atrial Fibrillation (1729); Bradycardia (1751)
Event Date 05/04/2015
Event Type  Injury  
Event Description
It was reported on (b)(6) 2015 that the patient is experiencing very severe bradycardia with no evidence of asystole.This was diagnosed on (b)(6) although it may have started earlier.The patient is showing signs of atrial fibrillation followed by bradycardia as low as 20bpm.The device was deactivated with a pacemaker magnet and the patient showed no bradycardia after the magnet deactivation.The patient's device was then disabled to 0ma.
 
Event Description
The patient's following physician is aware of the situation and that the device was turned off by the icu.The patient has not seen the patient since the event and is unwilling to provide any additional information.Therefore, attempts for additional information have been made but no relevant information has been received to date.
 
Manufacturer Narrative
Review of the available programming and diagnostic history.
 
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Brand Name
PULSE GEN MODEL 102
Type of Device
GENERATOR
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058 770
Manufacturer (Section G)
CYBERONICS, INC.
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston, TX 77058
2812287200
MDR Report Key4802826
MDR Text Key5898387
Report Number1644487-2015-04798
Device Sequence Number1
Product Code LYJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P970003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Health Professional
Type of Report Initial,Followup
Report Date 05/04/2015
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? No
Device Operator Lay User/Patient
Device Expiration Date11/30/2009
Device Model Number102
Device Lot Number1970
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Event Location Other
Initial Date Manufacturer Received 06/23/2015
Initial Date FDA Received05/28/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received07/14/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/19/2007
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age52 YR
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