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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 Detachment Of Device Component
Event Date 02/11/2017
Event Type  Malfunction  
Event Description

It was reported the patient underwent repositioning surgery for patient comfort. During the surgery, the surgeon had unscrewed the setscrew so that the vns generator could be removed from the lead for repositioning. It was noted the septum was no longer lying flat and it was explained that it could be pushed back down flush as it likely dislodged while unscrewing the setscrew. It was later explained the vns generator had to be replaced as the septum popped out when the surgeon attempted to push it back down flush. The device history record was reviewed and confirmed the vns generator passed all tests prior to distribution. The vns generator was received by the manufacturer. While analysis is expected, it has not been completed to date.

 
Event Description

Analysis was completed on the received generator however it was noted that the septum was not received. During analysis the generator performed to functional specification. During dimensional assessment, the header septum cavity was measured and found to be outside of specification (higher than the maximum upper limit). The header lead cavity was measured and found to meet specification. Receiving inspection documentation was reviewed for the lot of septum cavities used to manufacture the generator. No anomalies were observed with the sampled septum cavities. A company representative reported that the following explant the generator left the or and underwent a process prior to being returned to the manufacturer. It was unclear what type of sterilization process the generator may have been exposed to that could have potentially affected the dimensions of the septum cavity. Further follow-up with the explanting facility found that there was no record of the generator undergoing additional sterilization after explant and prior to return to the manufacturer. The cause of the out of specification septum cavity could not be determined as it was unclear if the generator was exposed to additional sterilization after explant.

 
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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 Key6600771
Report Number1644487-2017-03900
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 07/07/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/31/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/07/2018
Device MODEL Number106
Device LOT Number203851
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/17/2017
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received06/14/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/20/2016
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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