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

Model Number DB-2201-30DC

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 06/15/2021

Event Type  Injury  

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 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
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 12278544
• MDR Text Key: 265127346
• Report Number: 3006630150-2021-04294
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 08714729836490
• UDI-Public: 08714729836490
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P150031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention