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

Model Number 300-20

Device Problems Material Separation (1562); Sticking (1597); Battery Problem (2885)

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

Event Date 03/01/2016

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: corrected data: yes.Initial mdr inadvertently marked that the product was not returned to manufacturer.However, the product was received and an evaluation of the product was provided in the initial mdr.

Event Description

An implant card was received indicating that the patient underwent full revision surgery due to battery depletion of the generator and lead pin being stuck in the generator that was to be explanted.During a generator replacement surgery on (b)(6) 2016, the surgeon had difficulties removing the second lead pin from the dual pin generator.The screwdriver was used to try to relieve the pressure and the pin was eventually removed, but the lead pin was "stripped" during the removal process.It was also noted that the first lead pin was difficult to remove as well.The surgeon pilled the pin out so hard that the lead separated and a back string was visible within the lead.A full revision of the lead and generator was performed and the explanted generator and a portion of the lead were received on (b)(4) 2016.The reported ¿end of service and low battery¿ allegations were confirmed in the pa lab; an open can measurement of the battery voltage determined that the battery was depleted.The end of service condition was the result of normal, expected battery depletion based on the battery life calculation, the electrical test results and the bench evaluation.Although the device communicated at decontamination at zero inch distance (it did not communicate in the pa lab at zero inch distance), the reported ¿failure to program¿ allegation was duplicated in the pa lab and determined to be the result of normal battery depletion.The device performed according to functional specifications.Analysis of the generator in the pa lab concluded that no abnormal performance or any other type of adverse condition was found.Visual analysis confirmed that there were white deposits on the can, in the header and in the negative connector block/set screw area.A sem analysis of the foreign matter indicated that it was calcium and phosphorus.The reported ¿difficulty removing the lead during revision surgery¿ most likely was caused by the white deposits on the negative septum and in the negative connector block/set screw area.An analysis was performed on the returned lead portions and the reported ¿fracture of leads' allegation was not confirmed.A majority of the lead assembly (body) including the connector pin / boot sections with model and serial number tag was not returned; therefore it was not possible to verify the model and serial number during this analysis and a complete evaluation could not be performed on the entire lead product.The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure.No obvious anomalies were noted.Continuity checks of the returned lead portions were performed, during the visual analysis, with no discontinuities identified.Based on the findings in the product analysis lab, there is no evidence to suggest discontinuities in the returned portions of the device which may have contributed to the stated allegation of ¿fracture of leads.'.

• Brand Name: BIPOL LEAD MODEL 300
• Type of Device: LEAD
• 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: 5540011
• MDR Text Key: 41846525
• Report Number: 1644487-2016-00681
• 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
• Report Date: 03/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2001
• Device Model Number: 300-20
• Device Lot Number: 23672C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 03/31/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/02/1999
• 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: 48 YR