MAUDE Adverse Event Report: CELESTICA ELECTRONICS S PTE LTD BIS; ELECTRODE, CUTANEOUS

Model Number 186-0106

Device Problem High Readings (2459)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

According to the reporter, the consultant used a neuro-muscular stimulator on the side of the temple in conjunction with the device.When activated, it's not uncommon for bis to register the electromagnetic interference in the raw eeg (and occasionally see an elevated bis number).However, in this instance, although the eeg displayed interference and the bis index number rose when the stimulator was used, the elevated number and interference in the eeg remained for a period of time after activation of the neuro stimulator.The consultant was concerned that the neuro-stimulator - a new device for them, was discharging residual current to cause this phenomenon with bis.The product will be reported separately.The other concern is that the anesthetist, believing the patient could potentially be light and at risk of intra-operative awareness, deepened the anesthesia meaning the patient took longer to wake up and recover.There were no injuries, side effects or complications from the case other than those stated here.

Manufacturer Narrative

D10 concomitant product: (b)(6) intl vista bis monitor w accy (lot#vt54885) this report is being submitted as part of a retrospective review and remediation per crp no.(b)(4).Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: BIS
• Type of Device: ELECTRODE, CUTANEOUS
• Manufacturer (Section D): CELESTICA ELECTRONICS S PTE LTD; no. 6 serangoon north avenue 5; singapore 55491 0; SN 554910
• Manufacturer (Section G): CELESTICA ELECTRONICS S PTE LTD; no. 6 serangoon north avenue 5; singapore 55491 0; SN 554910
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 18634262
• MDR Text Key: 334458055
• Report Number: 2936999-2024-00214
• Device Sequence Number: 1
• Product Code: GXY
• UDI-Device Identifier: 20884521134307
• UDI-Public: 20884521134307
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K093183
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2018
• Device Model Number: 186-0106
• Device Catalogue Number: 186-0106
• Device Lot Number: 186-0106
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/08/2021
• Initial Date FDA Received: 02/02/2024
• 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
• Treatment: SEE H10.
• Patient Age: 69 YR
• Patient Sex: Male