MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION; 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	Hypersensitivity/Allergic reaction (1907)
Date of Event	06/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: event date unknown.Additional suspect medical device components involved in the event: product family: dbs-linear leads, upn: m365db220130dc0, model: db-2201-30dc, serial: (b)(4), batch: 5155721.Product family: dbs-linear leads, upn: m365db220130dc0, model: db-2201-30dc, serial: (b)(4), batch: 5155722.Product family: dbs-linear leads, upn: m365db220130dc0, model: db-2201-30dc, serial: (b)(4), batch: 5155723.
Event or Problem Description
It was reported the patient presented with suspected infection.However, the physician assessed that the patient's symptoms were due to a suspected hypersensitivity to the polyurethane found in the leads.Topical hydrocortisone was applied and oral prednisolone was prescribed.The patient's symptoms had subsided, and the device remains implanted.

• Brand Name: NA
• 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: 12278544
• Report Number: 3006630150-2021-04294
• Device Sequence Number: 17417579
• Product Code: MHY
• UDI-Device Identifier: 08714729836490
• UDI-Public: 08714729836490
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/04/2021

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/02/2018
• Device Model Number: DB-2201-30DC
• Device Catalogue Number: DB-2201-30DC
• Device Lot Number: 19535460
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/03/2021
• Initial Report FDA Received Date: 08/04/2021
• 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