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

Model Number	DB-9218-15
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	02/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional suspect medical device component involved in the event: product family: dbs-ipg-r-mri, upn: (b)(4), model: db-1200-s, serial: (b)(4), lot: 737256.
Event or Problem Description
It was reported that the patient had a non-device related fall that resulted in a wound near the patient's non-boston scientific burr hole cover.The patient developed an infection at the non-boston scientific burr hole cover, lead, lead extension and the boston scientific m8 lead adapter site.The patient was administered antibiotics and underwent an explant procedure where the boston scientific lead adapter and the non-boston scientific devices were removed.During the procedure, a swab was taken at the boston scientific ipg site and it was also found to be positive for an infection.The patient underwent an additional surgical procedure where the ipg was explanted.The patient was stable post-operatively.The explanted m8 adapter and ipg will not be returned for analysis as the devices were kept by the medical facility.
Additional Manufacturer Narrative
Additional suspect medical device components involved in the event: product family: dbs-ipg-r-mri, upn: m365db1200s0, model: db-1200-s, serial: (b)(6), lot: 737256.Product family: dbs-adapters, upn: m365db9218150, model: db-9218-15, serial: (b)(6), lot: 7010253.
Event or Problem Description
It was reported that the patient had a non-device related fall that resulted in a wound near the patient's non-boston scientific burr hole cover.The patient developed an infection at the non-boston scientific burr hole cover, lead, lead extension and the boston scientific m8 lead adapter site.The patient was administered antibiotics and underwent an explant procedure where the boston scientific lead adapter and the non-boston scientific devices were removed.During the procedure, a swab was taken at the boston scientific ipg site and it was also found to be positive for an infection.The patient underwent an additional surgical procedure where the ipg was explanted.The patient was stable post-operatively.The explanted m8 adapter and ipg will not be returned for analysis as the devices were kept by the medical facility.Additional information was received that a second lead extension was also explanted.The patient was healing 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: 11627296
• Report Number: 3006630150-2021-01434
• Device Sequence Number: 11562357
• Product Code: MHY
• UDI-Device Identifier: 08714729905196
• UDI-Public: 08714729905196
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2021

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: 02/07/2020
• Device Model Number: DB-9218-15
• Device Catalogue Number: DB-9218-15
• Device Lot Number: 7010178
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/07/2021
• Supplement Date Received by Manufacturer: 04/07/2021
• Initial Report FDA Received Date: 04/07/2021
• Supplement Report FDA Received Date: 04/07/2021
• 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: 73 YR