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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 Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/30/2014
Event Type  Death  
Manufacturer Narrative

(b)(4).

 
Event Description

Explanted devices were received from another medical device manufacturer. The reason for explant was not indicated; however, an obituary search indicated that the patient implanted with the devices was deceased on (b)(6) 2014. Product analysis was performed on the explanted lead and generator. Analysis was approved for on the returned generator. An end-of-service message was observed on the generator. Review of the data downloaded from the indicated increased impedance; the pre-change impedance value was 1705 ohms, and the post-change value was 19911 ohms. The time of change detection (b)(6) 2014, indicating likely explant on this date. The pulse generator was tested and performed according to functional specifications, and there were no adverse conditions found with the generator. Analysis was approved for the lead. No discontinuities were identified within the returned lead portion. Setscrew marks were observed on the connector pin, providing evidence that proper contact between the setscrew and the connector pin existed at least once. Microscopy showed that pitting occurred on the surface of the connector ring. The most likely cause for the observed pitting condition is that the generator was not programmed off at the time of explant. Note that since a significant portion of the lead, including the electrode array, was not returned for analysis, an assessment cannot be made on that portion of the lead. No anomalies were identified in the returned lead portion. No additional relevant information has been received to date. The circumstances of the device explant have not been confirmed to date.

 
Event Description

A representative of the following neurologist's facility confirmed that the patient was deceased. The representative did not provide a cause of death for the patient. Clinic notes on file for the patient indicated that the patient was admitted to the hospital for abdominal pain and was pronounced dead two days later. It was unknown whether the patient's abdominal pain was related to the patient's death or to the vns. The representative did not provide an assessment regarding the relationship of the patient's death to vns. No additional relevant information has been received to date.

 
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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 Key7073931
Report Number1644487-2017-04865
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 12/29/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/01/2017
Is This An Adverse Event Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/31/2014
Device MODEL Number103
Device LOT Number202105
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/02/2017
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received12/15/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/09/2012
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: 12/01/2017 Patient Sequence Number: 1
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