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 Erosion (1750); Discomfort (2330)

Event Date 10/23/2023

Event Type  Injury  

Event Description

It was reported that a deep brain stimulation (dbs) patient experienced discomfort on the right side of their head.The patients dbs lead extensions were extruding in between the sutures of the incision per the physicians assessment.The physician confirmed there were no signs of infection, however it is unknown if cultures were taken.The patient underwent a procedure where the dbs lead extensions were placed underneath the skin and re-sutured the incision.

Manufacturer Narrative

Block b3: approximated based on the date the manufacturer became aware of the event.Additional suspect medical device components involved in the event: product family: upn: m365nm3138550.Model: nm-3138-55.Serial: (b)(6).Batch: 7107333.

Manufacturer Narrative

Block b3: approximated based on the date the manufacturer became aware of the event.

Event Description

It was reported that a deep brain stimulation (dbs) patient experienced discomfort on the right side of their head.The patients dbs lead extensions were extruding in between the sutures of the incision per the physicians assessment.The physician confirmed there were no signs of infection, however it is unknown if cultures were taken.The patient underwent a procedure where the dbs lead extensions were placed underneath the skin and re-sutured the incision.Additional information was received that an incision was made around the exposed lead extension area and about one centimeter of the skin was removed.The physician cleaned the wound, placed the dbs lead extensions under the skin and re-sutured the incision.The patient did well post-operatively.

• 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; road 698, lot no. 12; dorado PR 00646 -260; * 00646-2602
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 18164987
• MDR Text Key: 328447321
• Report Number: 3006630150-2023-07154
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 08714729820765
• UDI-Public: 08714729820765
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup
• Report Date: 12/15/2023

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
• Device Operator: Lay User/Patient
• Device Model Number: NM-3138-55
• Device Catalogue Number: NM-3138-55
• Device Lot Number: 7109765
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/23/2023
• Initial Date FDA Received: 11/17/2023
• Supplement Dates Manufacturer Received: 11/20/2023
• Supplement Dates FDA Received: 12/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/03/2023
• 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
• Patient Age: 67 YR
• Patient Sex: Female