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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 04/04/2012
Event Type  Injury  
Event Description

On (b)(6) 2012, clinic notes from a vns treating neurologist were received by the manufacturer. Review of the clinic notes dated (b)(6) 2012 revealed that the patient was experiencing breakthrough seizures at the patient's previous visit. On (b)(6) 2012 the patient's generator was reported to have physically slipped about 1 inch downward and was causing the patient significant pain at the generator site. The patient was referred to a surgeon for evaluation and possible re-implant to fix the migration. Additional information has been requested from the physician but no further information has been received to date.

 
Event Description

Additional information was received on (b)(6) 2012, when product analysis was completed on the generator. In the pa lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications and there were no performance or any other type of adverse conditions found with the pulse generator.

 
Event Description

Additional information was received on (b)(4) 2012 when it was discovered that the vns patient had prophylactic generator replacement that day. Pre-op normal mode diagnostics showed a dcdc code of 4 and lead impedance=ok. The patient's old settings were output=2ma/frequency=30hz/pulse width=500usec/on time=30sec/off time=5min/magnet output=2ma/magnet pulse width=500usec/magnet on time=60sec. The generator was relocated to the right side of chest per patient request. System diagnostic performed in or with new generator showed results within normal limits of dcdc=2/lead impedance=ok. The patient's device was turned on in the o. R. And programmed to output=1. 5ma/frequency=30hz/pulse width=500usec/on time=30sec/off time=5min/magnet output=1. 75ma/magnet pulse width=500usec/magnet on time=60sec. The explanted generator was returned to the manufacturer on (b)(4) 2012 for product analysis that is still underway and has not yet been completed.

 
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Brand NamePULSE GEN MODEL 102R
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058 770
Manufacturer (Section G)
CYBERONICS, INC.
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
nydia herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2561466
Report Number1644487-2012-01149
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/11/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/07/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/31/2008
Device MODEL Number102R
Device LOT Number016111
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/28/2012
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received07/30/2012
Was Device Evaluated By Manufacturer? No
Date Device Manufactured10/03/2006
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: 05/07/2012 Patient Sequence Number: 1
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