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

Model Number DB-3128-55B

Device Problems High impedance (1291); Defective Device (2588)

Patient Problem Shaking/Tremors (2515)

Event Date 12/01/2023

Event Type  Injury  

Manufacturer Narrative

Block b3: exact date unknown, event occurred in 01dec2023 and 10dec2023.

Event Description

It was reported the patient experienced inadequate therapy and the return of their tremors from their deep brain stimulation (dbs) device.It was noted that attempts to reprogram were not performed due to high impedances found on several left lead contacts.The patient underwent a procedure where an incision was made at the dbs lead extension and implantable pulse generator (ipg) site where the physician noted the lead extension had been severed.The physician completed the procedure by replacing the lead extension with another of the same model and impedances were within normal range before suturing incision.It was uncertain how the dbs lead extension could have been severed per the physicians assessment.The patient did well post-operatively.

Manufacturer Narrative

Analysis of the returned dbs lead extension visual inspection revealed that the proximal array was fractured close to the vent port.A labeling review identified that the device was used per the instructions for (ifu)/product label.Additionally, labeling states failure or malfunction of the device, including lead extension breakage whether the problem requires removal and/or replacement additionally loss of stimulation are known risks with the use of the dbs.Based on a review of all the available information the reported event was confirmed, and engineers concluded the probable cause traced due to component failure.

Event Description

It was reported the patient experienced inadequate therapy and the return of their tremors from their deep brain stimulation (dbs) device.It was noted that attempts to reprogram were not performed due to high impedances found on several left lead contacts.The patient underwent a procedure where an incision was made at the dbs lead extension and implantable pulse generator (ipg) site where the physician noted the lead extension had been severed.The physician completed the procedure by replacing the lead extension with another of the same model and impedances were within normal range before suturing incision.It was uncertain how the dbs lead extension could have been severed per the physicians assessment.The patient did well post-operatively.

• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS
• 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: 18728661
• MDR Text Key: 335711939
• Report Number: 2124215-2024-09509
• Device Sequence Number: 1
• Product Code: NHL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/30/2024

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
• Device Operator: Lay User/Patient
• Device Model Number: DB-3128-55B
• Device Catalogue Number: DB-3128-55B
• Device Lot Number: 5000320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/22/2024
• Initial Date FDA Received: 02/18/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2022
• 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: 70 YR
• Patient Sex: Male
• Patient Race: White