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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
Event Date 01/13/2010
Event Type  Injury  
Event Description

Additional information was received that the patient¿s arm paralysis was approximately six years prior. The event had resolved, was no longer an issue, and was not believed to be related to vns.

 
Event Description

Clinic notes dated (b)(6) 2013 indicated that the patient suffered from seizures, headaches, and hemiparesis. Clinic notes dated (b)(6) 0213 indicated that the patient experienced increased back pain and that her hips were still sore because of injections. Clinic notes dated (b)(6) 2013 indicates that the patient had increased back pain with a possible event in her hips. The patient had to use her magnet over the last few days. Additional information was received indications that provided recent diagnostics results. The patient was referred for generator replacement. Surgery is likely but has not taken place.

 
Event Description

On (b)(6) 2013, this vns patient underwent generator revision. The explanted generator was returned on (b)(4) 2013 and is pending analysis.

 
Event Description

The generator analysis was completed on (b)(4) 2013. An end-of-service warning message was verified in the pa lab and found to be associated with the output being disabled by the pulse generator. Burn marks were observed on the pulse generator case, which indicated that the pulse generator may have been exposed to an electro-cautery tool during device explant. A reset of the pulsedisable bit in the generator memory was performed to allow for an output to once again be provided by the generator for subsequent testing. 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. The battery shows a non-ifi condition. Other than the noted condition, there were no performance or any other type of adverse conditions found with the pulse generator.

 
Event Description

On (b)(6) 2013, it was reported that this vns patient was having breakthrough seizures and now feels tired all the time. The patient reported that the generator was put in arm pit, a pointy thing sticking out of the armpit that she had to get used to. The patient wasn't sure if the surgery caused nerve damage for she had a problem with her arm for 1 year post operatively and could not move her arm. Surgery is likely but has not taken place.

 
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Brand NamePULSE GEN MODEL 103
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
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key3106886
Report Number1644487-2013-01331
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 04/12/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/10/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date05/31/2011
Device MODEL Number103
Device LOT Number201142
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/08/2013
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received08/27/2013
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/30/2009
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: 05/10/2013 Patient Sequence Number: 1
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