MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION STIM KIT VERCISE; STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)

Model Number DBS 45 CM DB-2201-45DC

Device Problems Break (1069); Failure to Advance (2524); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/03/2023

Event Type  malfunction  

Event Description

Patient was undergoing a stage 2 deep brain stimulator placement.During the case, the lead was inserted into the lead extension, but it would not fully engage and become properly seated.The lead just stopped advancing and would not continue to advance.Neurosurgeon attempted to salvage the lead by removing the extension that the lead was stuck in.Upon removal from the extension, it was discovered that the lead had become damaged from this incident.New lead extension placed and the leads were attached.

• Brand Name: STIM KIT VERCISE
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; marlborough MA 01752
• MDR Report Key: 16903379
• MDR Text Key: 315031537
• Report Number: MW5117427
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DBS 45 CM DB-2201-45DC
• Device Lot Number: 7073410
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 84 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White