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

Model Number	DB-2201-30DC
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Erosion (1750)
Date of Event	12/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: approximated based on the date the manufacturer became aware of the event.
Event or Problem Description
It was reported that the patient experienced one of the leads had migrated which caused protrusion from the scalp.Therefore, the patient had a lead revision to correct the lead protrusion.No further information could be obtained despite good faith effort.
Event or Problem Description
It was reported that the patient experienced one of the leads had migrated which caused protrusion from the scalp.Therefore, patient had a lead revision to correct the lead protrusion.No further information could be obtained despite good faith effort.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block d4: correction to initial mdr.

• Brand Name: VERCISE CARTESIA
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 13239909
• Report Number: 3006630150-2022-00034
• Device Sequence Number: 13703060
• Product Code: MHY
• UDI-Device Identifier: 08714729836490
• UDI-Public: 08714729836490
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/07/2018
• Device Model Number: DB-2201-30DC
• Device Catalogue Number: DB-2201-30DC
• Device Lot Number: 19000987
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/20/2021
• Supplement Date Received by Manufacturer: 03/14/2022
• Initial Report FDA Received Date: 01/12/2022
• Supplement Report FDA Received Date: 03/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown