MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SureTek?; stimulator, electrical, implanted, for parkinsonian tremor

Model Number	DB-4600-C
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/30/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block d.2b; additional applicable product codes: nhl, pjs additional suspect medical device components involved in the event: model number/catalog number: db-4600-c serial number: na batch/lot number: 38901393 model/catalog description: suretek burr hole cover kit unique identifier (udi) #:(b)(4).The device db-4600-c lot number 38960883 was not returned for analysis; therefore, a physical evaluation could not be performed, and the reported allegation(s) was/were not able to be confirmed.A review of the device history record (dhr) was conducted.The records indicate that the device met all applicable acceptance criteria and release requirements prior to distribution.No manufacturing-related nonconformances or deviations were identified during the review that could be associated with the reported event.A similar complaint review was completed using similar complaint review tool ((b)(4)), which reviewed 1375: difficult to use burr hole cover, 2732: damaged during surgery, and 9289: unretrieved device fragments (udf).The review did not identify any emerging trends, meaningful commonalities, or similar complaints requiring escalation.Therefore, no additional escalation is required.A risk review was completed and confirmed that the event of "[applicable ar-d(s): 1375: difficult to use burr hole cover, 2732: damaged during surgery; ar-p codes: 9289: unretrieved device fragments (udf); ai codes: f2301: additional device required, f1906: modified surgical procedure]" was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Evaluation of the complaint record did not identify objective evidence to confirm the reported allegation or determine a cause.Therefore, in the absence of device return and analysis the likely root cause could not be established.
Additional Manufacturer Narrative
Block d.2b; additional applicable product codes: nhl, pjs.Additional suspect medical device components involved in the event: model number/catalog number: db-4600-c.Serial number: na.Batch/lot number: 38901393.Model/catalog description: suretek burr hole cover kit.Unique identifier (udi) #: (b)(4).
Event or Problem Description
It was reported that during a deep brain stimulation (dbs) lead implantation procedure, the head of a screw from the burr hole kit sheared off while being tightened.The screw fragment remained retained in the bone.No patient injury or adverse effects were reported.Attempts were made to retrieve the retained screw fragment using a clamp; however, successful removal would have required drilling additional bone surrounding the screw, resulting in a larger bony defect.To avoid further complications, the decision was made to leave the screw fragment in place.It could not be determined which of the implanted burr hole cover kits was associated with the sheared screw.As part of the intervention, a new screw was used to complete the procedure and secure the implant as intended.Postoperatively, no patient complications related to the event were reported.
Event or Problem Description
It was reported that during a deep brain stimulation (dbs) lead implantation procedure, the head of a screw from the burr hole kit sheared off while being tightened.The screw fragment remained retained in the bone.No patient injury or adverse effects were reported.Attempts were made to retrieve the retained screw fragment using a clamp; however, successful removal would have required drilling additional bone surrounding the screw, resulting in a larger bony defect.To avoid further complications, the decision was made to leave the screw fragment in place.It could not be determined which of the implanted burr hole cover kits was associated with the sheared screw.As part of the intervention, a new screw was used to complete the procedure and secure the implant as intended.Postoperatively, no patient complications related to the event were reported.

• Brand Name: SureTek?
• Common Device Name: stimulator, electrical, implanted, for parkinsonian tremor
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION CORPORATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): Boston Scientific Corporation; 4100 hamline avenue north; saint paul MN 55112 -579
• Manufacturer Contact: ricardo amaro castro ; 25155 rye canyon loop; valencia, CA 91355 ; +1(320)800-7570
• MDR Report Key: 50063888
• Report Number: 3006630150-2026-05328
• Device Sequence Number: 18813327
• Product Code: MHY
• UDI-Device Identifier: 08714729820802
• UDI-Public: (01)08714729820802(17)280408(10)38960883
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2026

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
• Operator of Device: Health Professional
• Device Model Number: DB-4600-C
• Device Catalogue Number: DB-4600-C
• Device Lot Number: 38960883
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2026
• Supplement Date Received by Manufacturer: 09/10/2026
• Initial Report FDA Received Date: 07/28/2026
• Supplement Report FDA Received Date: 09/23/2026
• Date Device Manufactured: 04/09/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male