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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. BIPOL LEAD MODEL 300

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CYBERONICS, INC. BIPOL LEAD MODEL 300 Back to Search Results
Model Number 300-20
Event Date 05/01/2014
Event Type  Malfunction  
Event Description

The slice mark and abraded openings found on the outer silicone tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the outer silicone tubing. The abraded openings found on the inner silicone tubes and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the inner silicone tubes.

 
Event Description

Analysis of the returned lead portion was completed and confirmed lead discontinuity. Abraded openings of both inner tubing sections were found. There is evidence to suggest that both coils were in contact with each other, leading to a potential short circuit condition.

 
Manufacturer Narrative

Device failure occurred, but did not cause or contribute to death.

 
Manufacturer Narrative

Describe event or problem, corrected data: the supplemental report #1 inadvertently did not report this data.

 
Manufacturer Narrative

Device manufacture date, corrected data: the supplemental report #2 inadvertently did not report this data.

 
Event Description

It was reported that the vns patient¿s device was tested during an office visit on (b)(6) 2014 and diagnostic results revealed low impedance. The patient¿s device settings were increased but the patient did not exhibit any signs of receiving therapy. The physician¿s handheld device showed that low impedance was first observed at generator replacement surgery on (b)(6) 2014. The device impedance value fluctuated between < 600 ohms and 869 ohms since the replacement procedure. It was noted that the patient¿s previous generator showed low impedance (dc dc ¿ 0) prior to replacement. The physician stated that the patient had been experiencing an increase in seizures since (b)(6) 2014. An implant card was received indicating that the patient underwent generator and lead replacement surgery on (b)(6) 2014 due to lead discontinuity. The surgeon observed a lead break during explant. The explanted generator and lead were returned to the manufacturer for analysis. There were no performance or any other type of adverse conditions found with the pulse generator. Various electrical loads were attached to the generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances. Monitoring of the device output signal showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. Analysis of the returned lead portion is currently underway.

 
Manufacturer Narrative

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

 
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Brand NameBIPOL LEAD MODEL 300
Type of DeviceLEAD
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 Key4195520
Report Number1644487-2014-02793
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup,Followup,Followup
Report Date 09/29/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/23/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date05/31/2001
Device MODEL Number300-20
Device LOT Number22821C
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/09/2014
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received11/25/2014
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/14/1999
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: 10/23/2014 Patient Sequence Number: 1
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