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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 06/12/2012
Event Type  Malfunction  
Event Description

On (b)(4) 2012, it was reported that this vns patient would be undergoing surgery for an unknown reason. Follow up on (b)(6) 2012 with the patient's physician revealed that the patient was last seen on (b)(6) 2012, and the patient's device indicated ifi = yes. The patient had a surgical consult on (b)(6) 2012, and it was reported that the patient's battery was completely depleted. The device could not be interrogated; however, as the generator is a model 103 generator, interrogation should be possible regardless of battery status. The programming system was ruled out as the reason for the failure to communicate. The reporter was unsure as to the color of the ifi indicator from (b)(6) 2012. It was also stated that the patient had an increase in seizures. The relation of this increase seizures to the pre-vns seizure frequency is unknown; however, it was stated that the increase in seizure is attributed to the depleted battery. Surgery is likely but has not occurred to date.

 
Event Description

On (b)(6) 2012, confirmation of surgery on (b)(6) 2012, was received for this patient. Additional information was received on (b)(6) 2012, that there were complications during the surgery and high impedance was seen. The high impedance report is captured in mfr report #1644487-2012-01923 follow up with the physician on (b)(6) 2012, revealed that on (b)(6) 2012, diagnostics were normal and ifi=yes was seen. High impedance was seen on (b)(6) 2012 and diagnostics showed that the device was at end of service. Operative notes were also received on (b)(6) 2012. The notes indicated that in the surgery, the old generator was removed and a new generator was replaced and secured. Multiple attempts with integrity testing with the eef lab technician were unsuccessful, deeming a lead failure. The notes reported that dissection down through the subcutaneous tissue encountered quite a bit of scarring and inflammatory response, but there were no signs of infection. The internal carotid artery was identified, as was the jugular vein which was large for his size. The vagus nerve was identified with the vns device on the vagus nerve a, and it was quite enlarged, consistent with some inflammatory response around the device and the nerve. While trying to dissect up above the device, there was a small tear created in the jugular vein and immediately quite a bit of blood was noted to be coming from the wound. Due to the blood loss and the ongoing inflammatory response in the neck, it was decided that the patient¿s surgery would be postponed until another day. The device was amputated in the chest, and with careful inspection, there was a question of whether there was a crack about four centimeters from the insert of the generator. The tear in the jugular vein was due to the adhesion to vagal nerve stimulator lead. The device was reportedly returned to the manufacturer for review; however, it has not been received. The notes stated that the plan would be to obtain authorization to have the entire device, lead and generator, replaced on (b)(6) 2012, confirmation was received that this patient had undergone generator and lead implant surgery on this date. Attempts for product return have been unsuccessful.

 
Event Description

The patient was re-implanted on (b)(6) 2012.

 
Event Description

Product analysis for the generator implanted on (b)(6) 2012 and explanted on (b)(6) 2012 was approved on (b)(6) 2012. The device was returned at shipping settings indicating that the device was not programmed on. Results of diagnostic testing indicated the device was operating properly. Electrical test showed that the pulse generator was operating within specification. There were no adverse functional, mechanical, or visual issues identified with the returned generator. (this generator was returned along with the suspect medical device - generator on (b)(6) 2012. ) design history files for the explanted m103 generator (suspect medical device) were reviewed and showed that the device passed all functional tests prior to distribution.

 
Event Description

On (b)(6), 2012, the patient's explanted generator was returned for product analysis. Product analysis was approved on (b)(6), 2012. The generator was returned for a reported demipulse eos and failure to program condition. The reported failure to program was not duplicated in the pa lab. Results of diagnostic testing indicate the battery status shows neos=yes in the pa lab. The battery was found to be partially depleted and at ifi and neos.

 
Manufacturer Narrative

Analysis of programming history.

 
Manufacturer Narrative

Describe event or problem, corrected data: previously submitted mdr stated that the patient was re-implanted on (b)(6) 2012; however, the patient was actually re-implanted on (b)(6) 2012. This report is being submitted to correct this information.

 
Manufacturer Narrative

Description of event, corrected data: previously submitted mdr inadvertently omitted information that the patient's generator implanted and explanted on (b)(6) 2012 was received. This report is being to correct this information.

 
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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
nydia herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2615021
Report Number1644487-2012-01492
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 06/12/2012
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/13/2012
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/06/2010
Device MODEL Number103
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/06/2012
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received09/05/2012
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/23/2008
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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