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

Model Number	DB-9218-15
Medical Device Problem Codes	High impedance (1291); Charging Problem (2892)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional suspect medical devices: reference number: (b)(4), product family: dbs-adapters, upn: (b)(4), model: db-9218-15 serial: (b)(4), batch: 18878626.Reference number: (b)(4), product family: dbs-ipg-r, upn: (b)(4), model: db-1110c, serial: (b)(4), batch: 19735867.
Event or Problem Description
A report was received that a patient's lead adapters were explanted due to high impedances.The patient's ipg was also explanted due to frequent charging.After the replacement procedure, the impedances were normal.
Additional Manufacturer Narrative
Update to fields device available for evaluation, device evaluated by mfr.
Event or Problem Description
A report was received that a patient's lead adapters were explanted due to high impedances.The patient's ipg was also explanted due to frequent charging.After the replacement procedure, the impedances were normal.
Additional Manufacturer Narrative
Analysis of returned m8 adapter serial number (b)(4) passed all the required tests and revealed no anomalies.Analysis of returned ipg serial number (b)(4) passed all the required tests and revealed no anomalies.Analysis of the returned m8 adapter serial number 1075576 confirmed the complaint.Two cables (e1 and e2) were fractured at weld nugget of connector springs in the boot, and the damage was caused by pulling force.
Event or Problem Description
A report was received that a patient's lead adapters were explanted due to high impedances.The patient's ipg was also explanted due to frequent charging.After the replacement procedure, the impedances were normal.

• 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: 8049102
• Report Number: 3006630150-2018-61695
• Device Sequence Number: 19279458
• 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: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/26/2018

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: 02/15/2018
• Device Model Number: DB-9218-15
• Device Catalogue Number: DB-9218-15
• Device Lot Number: 18878626
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2018
• Initial Date Received by Manufacturer: 10/18/2018
• Supplement Date Received by Manufacturer: 11/07/2018; 11/21/2018
• Initial Report FDA Received Date: 11/07/2018
• Supplement Report FDA Received Date: 11/14/2018; 11/26/2018
• 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