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

Model Number	DB-9218-15
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/13/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
A report was received that high impedances were observed before completing ipg implantation.The physician attempted to wipe the electrode with gauze, but high impedance issue was not resolved.It was decided at that time to replace the lead with another of the same product.Patient is doing well post operatively.
Additional Manufacturer Narrative
Operator of device: lay user/patient.The returned vercise m8 adapter was analyzed and no anomalies were found.
Event or Problem Description
A report was received that high impedances were observed before completing ipg implantation.The physician attempted to wipe the electrode with gauze, but high impedance issue was not resolved.It was decided at that time to replace the lead with another of the same product.Patient is doing well post operatively.

• Brand Name: VERCISE
• 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: 8298018
• Report Number: 3006630150-2019-00338
• Device Sequence Number: 11367296
• Product Code: MHY
• UDI-Device Identifier: 08714729905196
• UDI-Public: 08714729905196
• 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: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2019

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/20/2020
• Device Model Number: DB-9218-15
• Device Catalogue Number: DB-9218-15
• Device Lot Number: 7007907
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2019
• Initial Date Received by Manufacturer: 01/10/2019
• Supplement Date Received by Manufacturer: 02/08/2019
• Initial Report FDA Received Date: 02/01/2019
• Supplement Report FDA Received Date: 03/06/2019
• 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