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

Model Number 3387S-40

Device Problems Unstable (1667); Human-Device Interface Problem (2949)

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

Event Date 01/28/2019

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider (hcp) via a manufacturer representative (rep) regarding their implantable neurostimulator (ins) for parkinson's dual.It was reported that after the lead was positioned, it was attempted to be fixed by using the stimloc, but it could not be fixed in a state when the lead came off even after being fixed.The hcp suspected the damage or malfunction to the stimloc and they tried fixing it again by using the stimloc, but nothing was being changed and it could not be fixed.It was considered the problem was with the lead itself, the lead, which had been inserted was removed and a new lead kid was used.This resolved the issue without problems and the procedure was completed.It was unknown if any environmental/external/patient factors may have led or contributed to the issue.No patient symptoms or further complications were reported as a result of this event.

Manufacturer Narrative

Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is complete.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Analysis of the lead (product id# 3387s-40) identified that conductor coils were crushed 8.5 cm from the distal end; consistent with overstress damage.The outer diameter of the tubing in the area was within specification.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: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• MDR Report Key: 8355941
• MDR Text Key: 136715786
• Report Number: 3007566237-2019-00430
• 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: 06/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3387S-40
• Device Catalogue Number: 3387S-40
• Device Lot Number: VA1NXS3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2019
• Initial Date Manufacturer Received: 01/29/2019
• Initial Date FDA Received: 02/20/2019
• Supplement Dates Manufacturer Received: 03/06/2019; 05/29/2019
• Supplement Dates FDA Received: 03/15/2019; 06/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention