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

Model Number	DB-4254
Medical Device Problem Codes	Use of Device Problem (1670); Human-Device Interface Problem (2949)
Health Effect - Clinical Code	Stroke/CVA (1770)
Date of Event	01/17/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
A report was received that during the deep brain stimulation (dbs) implant procedure the patient experienced a stroke as a result of a carotid dissection in the right hemisphere of the brain.The physician believes that the carotid artery was nicked while tunneling during the procedure.The left side of the patient exhibited limited mobility post-operatively.The dbs stimulation was programmed to provide the patient with tremor relief on the right side and to get the left side used to the stimulation effects.The patient will continue with rehabilitation for the left side to assist in regaining mobility.The tunneler was discarded by the facility.

• Brand Name: NA
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• MDR Report Key: 9696240
• Report Number: 3006630150-2020-00503
• Device Sequence Number: 14164171
• Product Code: MHY
• UDI-Device Identifier: 08714729896104
• UDI-Public: 08714729896104
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P150031
• 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
• Report Date (Section B): 02/11/2020

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 Expiration Date: 03/21/2020
• Device Model Number: DB-4254
• Device Catalogue Number: DB-4254
• Device Lot Number: 21879851
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/17/2020
• Initial Report FDA Received Date: 02/11/2020
• 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
• Patient Age: 66 YR