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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103; GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 103; GENERATOR Back to Search Results
Model Number 103
Device Problems Energy Output Problem (1431); Unexpected Therapeutic Results (1631); Device Displays Incorrect Message (2591)
Patient Problems Seizures (2063); Therapeutic Response, Decreased (2271)
Event Date 11/16/2016
Event Type  malfunction  
Event Description
The physician reported seeing a message indicating that the patient was not receiving the intended output current from his generator.Diagnostics were available from the patient¿s (b)(6) visit and show that the results were with in normal limits.Recently the patient had been experiencing an increase in seizures that the physician attributes to lower than programmed output current being delivered.Using ohms law, it was found that the generator should be able to deliver 3.125ma, which is well above the programmed 2ma the patient's generator was set to.No other relevant information has been received.
 
Event Description
High impedance was previously observed with the same generator and lead.Patient underwent explorative surgery in 2013, when the surgeon found that the lead and generator were twisted.After untwisting the leads the surgeon performed system diagnostics and saw that the patient¿s lead impedance was within normal limits.The devices were not replaced as a result.The high impedance and explorative surgery was previously reported in mfr.Report # 1644487-2013-00040.Intermittent high impedance was observed as the devices were not replaced, which can prevent the patient from receiving the intended output current from the generator.This may have contributed to the low output current warning the physician observed.Any further relevant information regarding the high impedance and low output current will be reported in mfr.Report # 1644487-2013-00040.
 
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Brand Name
PULSE GEN MODEL 103
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 Key6174184
MDR Text Key62699261
Report Number1644487-2016-02812
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 Initial,Followup
Report Date 01/19/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/14/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date09/14/2012
Device Model Number103
Device Lot Number201586
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Event Location Other
Date Manufacturer Received12/20/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/28/2010
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 Age13 YR
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