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

Model Number	NEU_INS_STIMULATOR
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Neck Stiffness (2434)
Date of Event	09/01/2013
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Other applicable components are: product id: 37085-95, serial# (b)(4), implanted: (b)(6) 2012, product type: extension.
Event or Problem Description
Information was received from a health care provider (hcp) of a clinical study via a manufacturer representative (rep) regarding a patient who was implanted with a neurostimulator for parkinson's dual.It was reported that there was a revision of the cable on (b)(6) 2016 due to the patient not being able to move their head in a full range; the device was repositioned.The etiology was noted as unlikely/unrelated to surgery, unlikely/unrelated to stimulation, possibly related to the system, unlikely/unrelated to medication, and possibly related to a pre-existing/underlying condition.The event resulted in surgical intervention to prevent permanent impairment to a body function or body structure.The event was considered completely resolved on (b)(6) 2013.No further complications were reported/anticipated.

• Brand Name: ACTIVA
• 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: 6503553
• Report Number: 2182208-2017-00683
• Device Sequence Number: 849517
• Product Code: MHY
• UDI-Device Identifier: 00613994384119
• UDI-Public: 00613994384119
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P960009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2017

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?: No
• Operator of Device: Health Professional
• Device Model Number: NEU_INS_STIMULATOR
• Device Catalogue Number: NEU_INS_STIMULATOR
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/19/2017
• Supplement Report FDA Received Date: 04/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention