MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION BSNV-8 ADAPTOR EXTENSION; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR

Model Number	EMBSNV20
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis #705304485:analysis information -- 2023-03-14 06:18:16 cst pli# 10 product id# embsnv20 below is unedited, system generated text based on the analysis finding code(s).The returned device was subjected to a series of standard tests that include but is not limited to visual inspection and electrical testing.The returned device passed all testing in the laboratory and no anomalies were identified.This regulatory report is being submitted as part of a retrospective review as part of remediation plan 411.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
The manufacturer representative (rep) reported that on june 29, 2022 during an animal study, high impedances / open (>40k ohms) was seen on contact 2.  it was noted that the implanted neurostimulator (ins) used is a pre-market device, but the adaptor-extension and the competitor lead used were post-market devices.    troubleshooting performed included reseating the adaptor in the implanted neurostimulator (ins) within the or, but contact 2 continued to show up as open.At explant, contact 2 showed an open with both the ins and with the handheld ohmmeter.It was noted that the boot was sutured / glued with medical adhesive to the adaptor and lead to keep fluid from getting in and affecting the ecap measurements, so the investigator did not definitively know if the adaptor was causing the high impedances.Fda confirmed receipt of non-mdt product notification.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: BSNV-8 ADAPTOR EXTENSION
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer Contact: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 20001870
• Report Number: 2182207-2024-03560
• Device Sequence Number: 7414731
• Product Code: LGW
• UDI-Device Identifier: 00763000278267
• UDI-Public: 00763000278267
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/01/2024
• Device Model Number: EMBSNV20
• Device Catalogue Number: EMBSNV20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2022
• Supplement Date Received by Manufacturer: 08/28/2024
• Initial Report FDA Received Date: 08/20/2024
• Supplement Report FDA Received Date: 08/28/2024
• Date Device Manufactured: 08/27/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown