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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 106; GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 106; GENERATOR Back to Search Results
Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Infection (1930)
Event Date 07/11/2017
Event Type  Injury  
Manufacturer Narrative
Device evaluated by mfr?, (b)(4).
 
Event Description
It was reported that the patient had an infection at both the lead and generator site.The patient was initially implanted approximately a month prior to the report.The manufacturer's device history records were reviewed and it was verified that the lead and generator were sterilized prior to distribution.No known relevant surgical intervention has occurred to date.No further relevant information has been received to date.
 
Event Description
It was reported that the patient's generator and lead were explanted.The patient reportedly had a tuberculosis infection.The patient reported that she went to the er on (b)(6) 2017 vomiting, swelling, and a feeling like she had something "pressing against her trachea." the er told her that her post-operative swelling was normal.The neurologist prescribed iv fluids and zofran.Then, she woke up with purulent discharge from her neck incision and she went to the er on (b)(6) 2017 where she was treated with antibiotics and after 24 hours was referred for explant and transferred via ambulance, she was diagnosed with a postoperative infection and treated.On (b)(6) 2017 they lavaged her device but on (b)(6) 2017 took her to the hospital and explanted her vns.No further relevant information has been received to date.
 
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Brand Name
PULSE GEN MODEL 106
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 Key6854331
MDR Text Key85593136
Report Number1644487-2017-04439
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,consum
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 10/09/2017
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 Date03/01/2019
Device Model Number106
Device Lot Number204061
Is the Reporter a Health Professional? Yes
Event Location Other
Initial Date Manufacturer Received 08/16/2017
Initial Date FDA Received09/11/2017
Supplement Dates Manufacturer Received09/12/2017
Supplement Dates FDA Received10/09/2017
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/23/2017
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) Other;
Patient Age48 YR
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