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

Model Number DB-3128-55

Device Problems Fracture (1260); High impedance (1291)

Patient Problem Undesired Nerve Stimulation (1980)

Event Date 02/15/2024

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the deep brain stimulation (dbs) patient experienced high impedances on both sides of the leads and a loss of therapeutic stimulation.The leads and lead extensions were tested intra-operatively and it was identified that one of the lead extensions was faulty.The physician explanted and replaced the faulty lead extension.Impedances were re-checked and observed to be within range.Upon explanting the lead extension, the lead snapped.Part of the lead extension remains in-situ.The patient was doing well postoperatively and was fully recovered.

• 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: 18871458
• MDR Text Key: 337290612
• Report Number: 3006630150-2024-01361
• Device Sequence Number: 1
• Product Code: NHL
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 03/08/2024

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 Expiration Date: 03/23/2024
• Device Model Number: DB-3128-55
• Device Catalogue Number: DB-3128-55
• Device Lot Number: 5000879
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/15/2024
• Initial Date FDA Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2022
• 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