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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 302

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CYBERONICS, INC. LEAD MODEL 302 Back to Search Results
Model Number 302-30
Device Problems High impedance; Improper or Incorrect Procedure or Method
Event Date 06/13/2012
Event Type  Malfunction  
Event Description

On (b)(6) 2012, a vns treating physician reported that the vns patient was at settings of output=2. 5ma/frequency=20hz/pulse width=250usec/on time=30sec/off time=3min/magnet output=2. 75ma/magnet on time=60sec/magnet pulse width=250usec. Diagnostics showed output=ok/lead impedance=ok/dcdc=3/eri=no. The patient was at these settings until (b)(6) 2011, when he was changed to a more rapid cycling of output=2. 5ma/frequency=20hz/pulse width=250usec/on time=14sec/off time=1. 1min/magnet output=2. 75ma/magnet on time=60sec/magnet pulse width=250usec. Diagnostics were still output=ok/lead impedance=ok/dcdc=3/eri=no. The physician commented that this patient has only been seen by him since (b)(6) 2010. The physician further stated that despite instructing the patient to return sooner, the patient was not seen again until (b)(6) 2012. The patient was reported to be doing much better, with seizures reduced from 2 per week to 2-3 per month. The patient is mentally handicapped so the physician believes that reporting is not great, but the patient does report continuing to feel the device in his throat during stimulation and there is a subtle change in his voice. The patient's parameters continue to be the same, however, his normal mode diagnostics show, output status=limit/output=2. 5ma/lead impedance=high/dcdc=7/eri=no. The physician reported that he feels the high impedance is due to a battery failure and not lead failure as there has not been any reported trauma or issue that would be expected to have damaged the lead. The patient still feels stimulation. Clinic notes were also received. Clinic notes dated (b)6) 2012, revealed that the patient has clearly improved with about 2-3 seizures per month, down from 6 per month last visit. The intensity and duration are about the same. The patient's mother called in the fall stating that the patient has some swelling at the vns site, but it resolved spontaneously. The patient's mother reported a significant decrease in the frequency of his seizures that is likely related to the rapid cycling of his vns, as no other medication changes were made. The physician stated that vns interrogation indicated, high lead impedance, which the physician attributes to battery failure, as the patient continues to report feeling stimulation intermittently. The physician commented that he had to re-program the patient to 30seconds on time, in order to run the diagnostics, and then he switched the patient back. The physician later reported on (b)(6) 2012, that he saw the patient again and system diagnostics were performed which also showed high impedance; output=limit/lead impedance=high/dcdc=7. The physician disabled the device due to high impedance and the patient was referred to a surgeon for replacement. The physician stated that he did not order any x-rays. The physician stated that no patient manipulation or trauma occurred that is believed to have caused or contributed to the high impedance. He also stated that the patient normally has voice alteration and is nothing atypical for the patient. The swelling was reported in (b)(6) and resolved spontaneously. He believed the swelling was at the generator location, but was unsure. It was also unknown if any patient manipulation or trauma occurred that is believed to have caused or contributed to the swelling. Although surgery is likely, it has not occurred to date.

 
Event Description

Additional information was received on (b)(6) 2012, when it was discovered that the vns patient underwent a full revision surgery that day. The leads were replaced due to high impedance and the generator was replaced for prophylactic reasons. The hospital reported that the products were discarded in surgery as the surgeon routinely asks the staff to discard the explanted devices.

 
Manufacturer Narrative

Analysis of programming history. Device failure is suspected, but did not cause or contribute to a death or serious injury.

 
Event Description

The physician reported that the revision surgery done on (b)(6) 2012 was very lengthy and difficult and that he had a long time recovering from it.

 
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Brand NameLEAD MODEL 302
Type of DeviceLEAD
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 Key2645547
Report Number1644487-2012-01716
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative,COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 06/14/2012
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/09/2012
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/31/2009
Device MODEL Number302-30
Device LOT Number1556
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received01/06/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/01/2006
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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