MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION IMPLANTABLE NEUROSTIMULATOR; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number NEU_INS_STIMULATOR

Device Problems Break (1069); High impedance (1291); Device Damaged by Another Device (2915)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/16/2020

Event Type  Injury  

Manufacturer Narrative

Other relevant device(s) are: product id: 3389-40, serial/lot #: (b)(4), implanted: (b)(6) 2020, ubd: 16-nov-2023, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the #3 contact of the distal lead end was damaged intraoperatively.The #3 electrode was pulled off the lead when the boot, and lead cap were removed from the lead end.There was also a wire slightly sticking out of the lead where the electrode would normally sit.The surgeon trimmed the wire as it was getting caught when fitting the boot over the lead prior to connecting it to the extension.Impedance testing showed electrode 3 was out of range, but all other electrodes were not impacted.The lead remained in use.

Manufacturer Narrative

H3: the returned lead (lot# va241nr) was subjected to a series of standard tests that include but is not limited to visual inspection and electrical testing.Analysis identified that the #3 conductor was broken at the proximal end of the lead; consistent with overstress damage.Analysis identified that the #3 connector was pulled off at the proximal end of the lead.The returned lead cap was subjected to a series of standard tests that include but is not limited to visual inspection and functional testing.The returned device passed all testing in the laboratory and no anomalies were identified.H6: evaluation coding updated.Result code c19 and conclusion code d14 apply to the lead cap.C13 and d11 apply to the lead.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.

Manufacturer Narrative

B1, b2, h1: updated due to receipt of lead.Section d information references the main component of the system, other applicable components are: product id 3389-40 lot# va241nr implanted: (b)(6) 2020 explanted: unknown product type lead product id neu_leadcap_acc lot# unknown product type accessory d9: the lead and leadcap were returned.H3: analysis results were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.H6: evaluation coding updated.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: IMPLANTABLE NEUROSTIMULATOR
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• MDR Report Key: 10697848
• MDR Text Key: 211958544
• Report Number: 2182207-2020-01098
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 12/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NEU_INS_STIMULATOR
• Device Catalogue Number: NEU_INS_STIMULATOR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2020
• Date Manufacturer Received: 12/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR