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

Model Number NM-3138-55

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

Patient Problems Scar Tissue (2060); Discomfort (2330); Swelling/ Edema (4577)

Event Date 09/07/2022

Event Type  Injury  

Manufacturer Narrative

Additional suspect medical device component involved in the event: product family: dbs-extension, upn: (b)(4), model: nm-3138-55, serial: (b)(4), batch: 20979566.

Event Description

It was reported that the patient experienced discomfort at the retro-auricular area, where the patient repetitively touched and moved the connection of the leads and extensions.The physician observed swelling and scarring in the area.The patient underwent a lead extension revision procedure.During the procedure, the physician noticed the extensions were knotted so the extensions were replaced.The patient was doing well post-operatively.The explanted lead extensions were kept by the facility.

• 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: 15452054
• MDR Text Key: 300211728
• Report Number: 3006630150-2022-04872
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 08714729820765
• UDI-Public: 08714729820765
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P150031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/09/2019
• Device Model Number: NM-3138-55
• Device Catalogue Number: NM-3138-55
• Device Lot Number: 20979566
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2017
• 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; Hospitalization