MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 106; GENERATOR

Model Number 106

Device Problems Fracture (1260); High impedance (1291)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/25/2015

Event Type  malfunction  

Event Description

A provider reported that a patient's device was exhibiting high lead impedance on (b)(6) 2015.X-rays provided to the manufacturer for review did not reveal any gross lead fractures or sharp angles, however a large portion of the lead could not be assessed due to the image quality of the submitted x-rays and the fact that a portion of the lead was behind the pulse generator.The lead connector pin could not be confirmed to be fully inserted into the generator connector block due to the image quality of the submitted x-rays.Additionally, electrode alignment, proper strain relief and tie-down use could not be assessed due to the image quality.The presence of a micro-fracture in the lead could be ruled out.Lead impedance measured on (b)(6) 2015 at the time of prophylactic generator replacement for this patient was measured to be within normal limits at 2387 ohms.Attempts for additional relevant information have been unsuccessful to date.No known surgical interventions have occurred to date.

Event Description

Clinic notes were received which confirmed that high lead impedance was observed on (b)(6) 2015 with a lead impedance value of 9,979 ohms.

Manufacturer Narrative

If follow-up, what type?, corrected data: mfr supplemental report #1 should have indicated 'correction' instead of 'additional information.'.

Event Description

New information received indicated that during revision surgery fluid was noted in the lead body and in the header of the generator before disconnection of the lead.The lead appeared to be fully inserted into the header.It was reported that the surgeon did not observe any damage to the lead body in the visible portion of the lead or the generator header.It was stated that the patient is a special-needs patient and is typically strapped in a wheelchair with limited mobility.Lead impedances with the prior device explanted 6 weeks prior to the observed high impedance indicated normal impedance measurements were seen at that time.The patient's generator and lead were explanted and replaced during the surgery without issue.An implant card for the new system was received which indicated that the reason for replacement was due to "lead discontinuity." the explanted products have not been returned to the manufacturer to date.

Event Description

It has been determined that the explanted products were likely discarded by the explanting facility and are therefore unable to be returned for product analysis.

Event Description

New information was received indicating that the explanted devices were still in possession of the explanting hospital.The explanted devices were subsequently returned to the manufacturer and are currently undergoing product analysis.

Manufacturer Narrative

Date received by manufacturer, corrected data: supplemental report #4 inadvertently indicated date received as (b)(6) 2015 instead of (b)(6) 2015.

Manufacturer Narrative

(b)(4).

Event Description

Analysis of the pulse generator revealed no functional anomalies and comprehensive electrical testing confirmed that the generator performed according to all functional specifications.The header septum plug was not returned with the generator and body fluid remnants were observed in the header septum cavity, connector blocks, and lead cavity.The canted spring in the header was observed to be damaged.A known working bench lead was able to be fully inserted into the header without issue.Review of generator memory revealed fluctuating lead impedance values, several of which are high (above the upper normal limit of 5,300 ohms), consistent with the report of high lead impedance from the user.The first high impedance value was noted the day after implant suggesting a lead pin insertion issue.Various electrical loads were attached to the generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances.Battery discharge was normal with an ifi = no condition noted.Other than the noted visual anomalies, there were no performance or any other type of adverse conditions found with the pulse generator.A portion of the lead was received in three segments.An abraded opening was identified in the outer silicone tubing, deemed to be due to wear.A superficial tear was also noted in the outer silicone tubing.Pitting was observed on the connector ring.Dried remnants of what appear to have once been body fluids were observed inside the inner and outer silicone tubing but no obvious point of entrances was noted other than the identified tubing opening and the cut ends of the lead segments.Two sets of setscrew marks were seen on the connector pin, providing evidence that proper contact between the setscrew and the lead pin existed at least once.However, a single setscrew mark was noted at the end tip of the connector pin suggesting that the lead connector was not inserted completely at one point in time.Note that since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.No discontinuities were identified within the returned lead portion.Other than the above mentioned observations, and typical wear and explant related observations, no other anomalies were identified in the returned lead portions.The pitting observed on the connector ring is likely due to fluid entering the generator lead cavity due to incomplete lead pin insertion.

• Brand Name: PULSE GEN MODEL 106
• Type of Device: GENERATOR
• 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 Key: 5143792
• MDR Text Key: 28487003
• Report Number: 1644487-2015-06028
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/30/2017
• Device Model Number: 106
• Device Lot Number: 203465
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 01/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/07/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 64 YR