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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102R GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 102R GENERATOR Back to Search Results
Model Number 102R
Event Date 04/13/2016
Event Type  Malfunction  
Event Description

It was reported by the physician that the patient's device was found to be programmed to 0ma output current on (b)(6) 2016. It was noted the patient was previously seen on (b)(6) 2016 and the device had been programmed to 2. 75ma, diagnostic results were ok, and the device was interrogated prior to the patient leaving the appointment. The physician tried to re-program the patient to 1. 25ma, but the patient gagged, and when he re-interrogated the device, it was set to 0ma again. The physician stated he was going to leave the patient off after learning that low impedance could be a short circuit, and leave the device programmed off because the patient gagged. It is unknown if low impedance was actually observed. The programming history database was reviewed and a battery life calculation was performed; however, the information available only went to 10/08/2014 and was not relevant to the issues which were observed in april and may of 2016. Attempts for additional relevant information have been unsuccessful to date.

 
Event Description

It was reported the patient underwent generator replacement surgery on (b)(6) 2016. It was noted the company representative tested the new m104 generator and diagnostics showed a dcdc value of 2, which is within normal limits. The surgeon asked the company representative why they were doing a lead revision and the company representative explained that is what the physician requested. The patients neck was somewhat contracted and the surgeon was concerned that he wouldn't be able to get adequate exposure to complete the revision. The surgeon spoke with the physician and the decided to only do a generator replacement and they did not replace the lead. Additional diagnostics were run with the patient's head in 3 different positions to rule out lead discontinuity. The surgeon was satisfied. The m104 generator was then attached to the existing lead, diagnostics were checked and found to be normal, and the generator was left off per the surgeon's request. The explanted generator was received by the manufacturer for analysis; however, analysis has not been completed to date. The returned product form (rpf) stated the generator was replaced prophylactically. The implant card was received by the manufacturer and showed that after the new m104 generator was placed, diagnostics showed 2380 ohms, which was within normal limits. Attempts for additional information have been unsuccessful to date.

 
Event Description

Product analysis was performed on the returned generator. The device output current was monitored for more than 24-hours while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the generator's output signal and demonstrated the device provided the expected level of output current for the entire monitoring period. The generator diagnostics were as expected for the programmed parameters. The generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the generator. Additionally programming history was received into the in-house programming history database and was reviewed. It was found that generator diagnostics were run, which programmed the device off. This is an expected event after running generator diagnostics. It was noted that the physician changed the patient's setting back, but then ran generator diagnostics again, causing the device to be programmed off once again. Generator diagnostics should only be run in the or while using a test resistor, prior to implanted the device into the patient. All other diagnostic results showed the generator was working properly.

 
Manufacturer Narrative

Brand name; corrected data: this information was inadvertently reported incorrectly on the initial mfr. Report. Type of device; corrected data: this information was inadvertently reported incorrectly on the initial mfr. Report. Model #, serial #, lot#, exp. Date, and other; corrected data: this information was inadvertently reported incorrectly on the initial mfr. Report. Operator of device; corrected data: this information was inadvertently reported incorrectly on the initial mfr. Report. If implanted, give date; corrected data: this information was inadvertently reported incorrectly on the initial mfr. Report.

 
Manufacturer Narrative

Brand name; type of device; model#, serial#, lot#, other; operator of device; if implanted, give date; corrected data: this information was incorrectly reported on the initial mfr. Report.

 
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Brand NamePULSE GEN MODEL 102R
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 Key5743402
Report Number1644487-2016-01416
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Reporter Occupation
Type of Report Followup,Followup,Followup,Followup
Report Date 05/26/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/22/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date12/31/2009
Device MODEL Number102R
Device LOT Number200704
OTHER Device ID Number11.0.4
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/06/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received11/22/2016
Was Device Evaluated By Manufacturer? Yes
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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