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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 01/30/2015
Event Type  Injury  
Event Description

Clinic notes state that the patient has had an increase in the number of seizures. It is stated that he has had a few more than usual. Patient does not know when last vns dosing was. The patient¿s depakote dose was increased. The patient was referred for battery change / possible revision due to painful stimulation. Good faith attempts for further information from the physician have been unsuccessful to date.

 
Event Description

Further information from the nurse stated that she did not know the exact reason for the onset of seizures. She had no diagnostics results available to provide. The nurse stated that clinic notes dated (b)(6) 2015 state that the patient was dosed but experienced coughing during titration but again diagnostics were not noted. The nurse was unable to comment on the location of the painful stimulation. The patient underwent full revision on (b)(6) 2015. Prior to replacement the device was interrogated and showed that the device was set to 0ma. A system diagnostic test was ran but was interrupted as the patient reacted to the stimulation as it was painful. It was also reported that the patient then went into surgery and a systems diagnostic was performed again after the patient had been sedated and the patient's body shook when the diagnostic was run. The diagnostic test was run pre-op and showed dcdc code 2 was seen there didn't appear to be any issues. Attempts for product return have been made but the product has not been received to date.

 
Event Description

It was reported that the patient's explanted lead and generator were discarded after surgery.

 
Manufacturer Narrative

 
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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
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key4541097
Report Number1644487-2015-03958
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 01/30/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/24/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/31/2013
Device MODEL Number102R
Device LOT Number201757
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received04/01/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/19/2011
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: 02/24/2015 Patient Sequence Number: 1
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