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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
Event Date 09/19/2016
Event Type  Injury  
Manufacturer Narrative

(b)(4).

 
Event Description

Information was received which indicates that the patient had their generator explanted due to an infection that was believed to have been caused by either the patient picking at the incision site or drooling on the incision site. The patient was then explanted and the leads were cut. The device history record was reviewed for both the patient's lead and generator. The generator was sterilized prior to leaving the facility and had a sterilization expiration date of 03/22/2018. The lead was sterilized prior to leaving the facility and had a sterilization expiration date of 10/01/2004. The explanted devices were disposed of by the explanting facility. No return is expected. No other relevant information has been received to date.

 
Event Description

Information was received from the physician indicating that the patient presented on (b)(6) 2016 with infection and dehiscence wound. The patient's generator was subsequently removed on the same day. No other relevant information has been received.

 
Manufacturer Narrative

Date of event, corrected data: supplemental mdr #1 inadvertently reported an inaccurate event date. The infection likely began prior to when the physician first noticed it in clinic. Therefore the date of implant is a more appropriate event date. Describe event or problem, corrected data: initial and supplemental #1 mdr inadvertently left off the increase in seizures the patient experienced following a settings change. Relevant tests/laboratory data, including dates, corrected data: initial and supplemental #1 mdr inadvertently left off the settings from (b)(6) 2016.

 
Event Description

The patient's caretaker reported that the patient experienced an increase in seizures following a settings change on (b)(6) 2016. The seizure log with the neurologist indicated that the patient had one 2 minute seizure on (b)(6) 2016. The patient's settings were then adjusted on (b)(6) 2016. Shortly after the patient became ill which may have contributed to the increase in seizures.

 
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Brand NamePULSE GEN MODEL 106
Type of DeviceGENERATOR
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 Key6175461
Report Number1644487-2016-02797
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Followup,Followup
Report Date 02/02/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/15/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/22/2018
Device MODEL Number106
Device LOT Number203778
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received01/18/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/03/2016
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: 12/15/2016 Patient Sequence Number: 1
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