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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 Insufficient Information (3190)
Patient Problems Seizures (2063); Therapeutic Response, Decreased (2271)
Event Date 06/01/2015
Event Type  malfunction  
Manufacturer Narrative
 
Event Description
It was reported that the patient has been seizure free for the entire last year, however the last month he had four seizures.The nurse practitioner noted that she is concerned that the generator may be nearing end of life.The nurse practitioner later reported that the patient has been having breakthrough seizures and that she is concerned the generator is nearing end of service.She indicated that they will monitor the patient and if he continues to have seizures then they will replace the vns generator.No causal or contributory programming changes, medication changes, or other external factors precede the onset of the increase in seizures.The nurse practitioner stated that the patient only has one type of seizure and that the patient has had three breakthrough seizures.
 
Event Description
Clinic notes were received regarding the patient's replacement.In the clinic notes it was mentioned that the patient had 4 seizures in (b)(6) 2015, which were the only seizures the patient had that year.The patient was referred for prophylactic generator replacement due to the battery life calculation provided to the physician.No surgical intervention has occurred to date.
 
Event Description
The patient had prophylactic generator replacement surgery on (b)(6) 2016.The explanting facility does not return product to the manufacturer.No further relevant information has been received to date.
 
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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
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 Key4959682
MDR Text Key23337572
Report Number1644487-2015-05405
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 company representative,health
Reporter Occupation Health Professional
Type of Report Followup,Followup
Report Date 07/15/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date08/31/2013
Device Model Number102
Device Lot Number201883
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Event Location Other
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/03/2015
Supplement Dates Manufacturer ReceivedNot provided
Not provided
Supplement Dates FDA Received09/01/2016
10/31/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/26/2011
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 Age49 YR
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