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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 05/02/2016
Event Type  Injury  
Manufacturer Narrative

(b)(4).

 
Event Description

It was reported that a vns patient was complaining of sporadic painful stimulation at the generator site and radiating down through his left arm starting. Clinic notes received indicate the symptoms started on (b)(6) 2016 and were more intense with magnet activation. The condition progressed to constant sensation of tightness in chest and shortness of breath of approx. 1 hour duration until he taped the magnet over the device. The symptoms were alleviated for around 24 hours following pulse width adjustment from 500usec to 250usec and frequency adjustment from 30hz to 20hz on (b)(6) 2016 but then recurred. Full diagnostics were performed on (b)(6) 2016 and lead impedance on (b)(6) 2016 was normal 3,093 ohms. It was stated that the lead impedance was checked in varying neck positions. The physician elected to disable the device on (b)(6) 2016 and the patient was referred to a surgeon for anticipated exploratory surgery to explant and replace generator due to presumed malfunction/bleeding of current of vns system. X-rays were taken but nothing conclusive could be diagnosed by the providers. The x-rays were not provided to the manufacturer for review. The generator was successfully explanted and replaced on (b)(6) 2016 with no complications noted. The explanted generator was discarded by the explanting facility.

 
Event Description

An implant card was subsequently received for the procedure on (b)(6) 2016 indicating that a normal lead impedance of 3,373 ohms was observed with the newly implanted generator in place.

 
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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 Key5685905
Report Number1644487-2016-01156
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Followup
Report Date 05/05/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/27/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/29/2017
Device MODEL Number106
Device LOT Number4553
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received05/27/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/08/2015
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: 05/27/2016 Patient Sequence Number: 1
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