BIPOL LEAD MODEL 300 300-20

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-27 for BIPOL LEAD MODEL 300 300-20 manufactured by Cyberonics - Houston.

Event Text Entries

[188029751] Lead and generator were received into product analysis for unknown reason. Attempt was made to obtain information on reason it was sent back, however was indicated by the facility no information was available and per their procedures they send back products without providing this information. Product analysis (pa) was completed on the generator and the device was monitored for 24 hours in a body temperature environment and was able to deliver output with no irregularities. The device performed according to functional specifications. Analysis in the pa lab concluded proper functionality of the pulse generator and that no abnormal performance or any other type of adverse condition was found. Product analysis (pa) was completed on the returned portion of the lead. Note that since a significant portion of the lead (including the electrode array) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. The lead had multiple specks in the marked connector pin that resembled pitting. The pa lab determined the specks indicated the pin was exposed to high temperature. This was corroborated by the melted appearance in the area. The specks were analyzed and showed high percentages of si, cr, o, c. The reason for this condition is unknown but it was noted that it had no obvious effect on the performance of the device. Pa also notes that the lead showed abrasions on the outer tubing due to wear. Other than the mentioned findings and those typically related to the explanted procedure, no other anomalies were identified in the returned lead portion. No additional relevant information has been received to date.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1644487-2020-00508
• MDR Report Key: 9888468
• Report Source: COMPANY REPRESENTATIVE,HEALTH
• Date Received: 2020-03-27
• Date of Report: 2020-03-27
• Date of Event: 2020-02-12
• Date Mfgr Received: 2020-03-04
• Device Manufacturer Date: 2001-05-23
• Date Added to Maude: 2020-03-27
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MRS. RACHEL KOHN
• Manufacturer Street: 100 CYBERONICS BLVD SUITE 600
• Manufacturer City: HOUSTON TX 77058
• Manufacturer Country: US
• Manufacturer Postal: 77058
• Manufacturer Phone: 2812287200
• Manufacturer G1: CYBERONICS - HOUSTON
• Manufacturer Street: 100 CYBERONICS BLVD SUITE 600
• Manufacturer City: HOUSTON TX 77058
• Manufacturer Country: US
• Manufacturer Postal Code: 77058
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: BIPOL LEAD MODEL 300
• Generic Name: LEAD
• Product Code: LYJ
• Date Received: 2020-03-27
• Returned To Mfg: 2020-02-11
• Model Number: 300-20
• Lot Number: 2998
• Device Expiration Date: 2003-04-28
• Operator: LAY USER/PATIENT
• Device Availability: R
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: CYBERONICS - HOUSTON
• Manufacturer Address: 100 CYBERONICS BLVD HOUSTON TX 77058 US 77058

Patients

Patient Number	Treatment	Outcome	Date
1	0		2020-03-27