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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 Detachment Of Device Component; Fracture; High impedance
Event Date 06/14/2017
Event Type  Malfunction  
Event Description

An implant card was received which reported that the patient underwent a lead and generator replacement due to high impedance and battery depletion. No additional relevant information has been received to date.

 
Manufacturer Narrative

Corrected data: expiration date; this information was inadvertently reported incorrectly on mfg. Report #0.

 
Event Description

It was reported that high impedance was observed during the last visit however at the previous visit the impedance was noted to be higher, although still within acceptable limits. At the surgery the lead's pin was re-inserted into the existing generator however the high impedance did not resolve. The generator and lead were then replaced. Acceptable impedance was observed with the new generator and new lead. The explanted products have not been received to date.

 
Event Description

It was reported that x-rays were taken prior to the surgery and the physician could not identify anything wrong with the lead. During the surgery the surgeon intended to complete pin insertion troubleshooting however he found that the set screw would not tighten and the high impedance remained. When the generator was explanted the septum plug (covering the set screw) and set screw feel out of the generator without any interference. A new generator was then connected to the existing lead and the impedance was found to be ok. The explanted generator was then put in a sterilization solution before being packaged to be returned for analysis however during the cleaning process the set screw and septum plug were misplaced. The manufacturing records for the generator were reviewed and confirmed that the generator passed quality control inspection prior to distribution. The generator was received and is currently pending analysis.

 
Event Description

Analysis was completed on the returned generator. Visual assessment found that the generator had scratches on the can and header consistent with manipulation that occurs during the explant procedure. It was noted that the septum and set screw were not received with the generator. Dimensional analysis confirmed that the header septum cavity meet specification requirements. A test resistor was secured in the header on the bench using a pa set screw. Then a series of interrogations and diagnostic tests found that the generator performed normally and the battery indicator was ifi = no. During electrical testing the generator performed to functional specification. Since the detached septum and set screw were not returned these components could not be analyzed.

 
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Brand NamePULSE GEN MODEL 103
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 Key6772300
Report Number1644487-2017-04263
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial
Report Date 12/15/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/07/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date04/14/2017
Device MODEL Number103
Device LOT Number203374
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/30/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received11/29/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/21/2015
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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