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

Model Number	DB-1140-S
Medical Device Problem Codes	Unexpected Therapeutic Results (1631); Low impedance (2285); Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/07/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a revision procedure, the ipg stopped functioning and had to be replaced.Once the ipg was replaced, the patient was fine.
Additional Manufacturer Narrative
Additional information: d10.It was reported that during a revision procedure, the ipg stopped functioning.The complaint was confirmed.Device communication could not be established due to asic u1 and battery damage.Exposing the ipg electronics to high voltage transients could cause the electrical short within the asic u1.Representative verified that patients ipg was turned off before surgery and that grounding pad was away from ipg.However, based on the signature of the damage, ipg was most likely exposed to electrocautery during the operation.The probable cause selected is unintended use error caused or contributed to event.
Event or Problem Description
It was reported that during a revision procedure, the ipg stopped functioning and had to be replaced.Once the ipg was replaced, the patient was fine.

• Brand Name: VERCISE PC
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• MDR Report Key: 10347944
• Report Number: 3006630150-2020-03179
• Device Sequence Number: 3399208
• Product Code: NHL
• UDI-Device Identifier: 08714729984467
• UDI-Public: 08714729984467
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2020

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: Lay User/Patient
• Device Expiration Date: 02/11/2021
• Device Model Number: DB-1140-S
• Device Catalogue Number: DB-1140-S
• Device Lot Number: 631464
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2020
• Initial Date Received by Manufacturer: 07/07/2020
• Supplement Date Received by Manufacturer: 09/02/2020
• Initial Report FDA Received Date: 07/30/2020
• Supplement Report FDA Received Date: 09/28/2020
• 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: Other