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

Model Number NEU_INS_STIMULATOR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Skin Erosion (2075)

Event Date 12/25/2018

Event Type  Injury  

Manufacturer Narrative

Medical devices: product id 3387s-40, implanted: (b)(6) 2010, product type lead.Product id neu_unknown_ext, product type extension.Information references the main component of the system.Other relevant device(s) are: product id: 3387s-40; product id: neu_unknown_ext.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a health care provider (hcp) via a manufacturer representative (rep) regarding a patient who was implanted with a neurostimulator (ins) for parkinson's disease.The skin where the lead was connected to the extension near the back of the left ear became thin.The lead and extension were exposed to the outside due to skin breakage.The patient was hospitalized and surgical intervention was scheduled for (b)(6) 2018.Repair was planned by plastic surgery physician.The skin was wrapped with gauze at the time of the report.The severity was not severe per physician, and causality was not known.No infectious disease occurred.The patient was alive with injury at time of the report.Impedances and condition of settings were checked and it seemed that the product worked normally.No further complications were reported.

Manufacturer Narrative

Concomitant medical products: product id 3387s-40, lot# unknown, implanted: (b)(6) 2010, product type lead, product id neu_u nknown_ext, serial# unknown, implanted: (b)(6) 2010, product type extension.If information is provided in the future, a supplemental report will be issued.

• Brand Name: UNKNOWN IMPLANTABLE NEUROSTIMULATOR
• 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: 8242021
• MDR Text Key: 132905567
• Report Number: 3007566237-2019-00134
• 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
• Report Date: 01/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NEU_INS_STIMULATOR
• Device Catalogue Number: NEU_INS_STIMULATOR
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 57 YR
• Patient Weight: 42