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

Model Number	NEU_INS_STIMULATOR
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/11/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The main component of the system and other applicable components are: product id: 3389s-40, lot# va176kq, product type: lead.
Event or Problem Description
A healthcare provider (hcp) via the manufacturer representative (rep) reported that the lead, or more likely the stylet, was bent out of box and therefore was not used for implantation.The cause of the bend in the lead is unknown.The surgery was continued with other leads and took place on (b)(6) 2016.The patient's indication for implant is unknown.
Additional Manufacturer Narrative
Analysis of the lead 3389s-40, stimloc dbs lot # va176kq found no anomalies.Analysis of the stylet found that the wire was bent out of box.(b)(4) corresponds to the lead, (b)(4) corresponds to the stylet.(b)(4) corresponds to the lead.(b)(4) corresponds to the stylet.
Additional Manufacturer Narrative
As no known root cause was found, (b)(4) is the most applicable code corresponding to the stylet.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.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• MDR Report Key: 6141068
• Report Number: 3007566237-2016-04233
• Device Sequence Number: 162102
• Product Code: MHY
• UDI-Device Identifier: 00613994981363
• UDI-Public: 00613994981363
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P960009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/15/2016

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 Model Number: NEU_INS_STIMULATOR
• Device Catalogue Number: NEU_INS_STIMULATOR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2016
• Initial Date Received by Manufacturer: 11/14/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided; 12/15/2016
• Initial Report FDA Received Date: 12/02/2016
• Supplement Report FDA Received Date: 12/12/2016; 12/15/2016; 09/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1