MAUDE Adverse Event Report: GREATBATCH PLYMOUTH LD MY SUTLES BP 4047 54CM; Implantable lead

Model Number	4047
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/15/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this implantable lead was part of the system revision due to infection.No adverse patient effects were reported.The implantable lead was surgically abandoned.
Event or Problem Description
It was reported that this implantable lead was part of the system revision due to infection.No adverse patient effects were reported.The implantable lead was surgically abandoned.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, additional information from product investigation indicates that the device was not returned for analysis; therefore, a technical analysis could not be performed.Good faith effort attempts were made to try and retrieve the device; however, response was not received.A risk review was not required.Furthermore, the event was not reportable in an eea or great britain country, then bsc was not responsible for training with no new hazard was identified.An effective ifu version was not available for this product because the product was no longer manufactured.Consequently, a labeling review was not conducted, as the manual cannot be revised for translation, wording, or graphics.A similar complaint review was completed using, global similar complaint review tool, which reviewed the infection and did not identify any emerging trends or similar complaints that require escalation.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of no problem detected.This supplemental report is being filed to correct the d9: device avail for eval; d9: device return date; g2: report source; h2: follow-up type; h3: device eval by manufacturer; and h11: additional mfr narrative.

• Brand Name: LD MY SUTLES BP 4047 54CM
• Common Device Name: Implantable lead
• Manufacturer (Section D): GREATBATCH PLYMOUTH; 2300 berkshire ln n; minneapolis MN 55441
• Manufacturer (Section G): GREATBATCH PLYMOUTH; 2300 berkshire ln n; minneapolis MN 55441
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(651)582-6168
• MDR Report Key: 25405630
• Report Number: 2124215-2026-30120
• Device Sequence Number: 10326796
• Product Code: DTB
• UDI-Device Identifier: 00821329900228
• UDI-Public: (01)00821329900228(11)231101(17)261101
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 4047
• Device Catalogue Number: 4047
• Device Lot Number: 342493
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/05/2026
• Supplement Report FDA Received Date: 08/19/2026
• Date Device Manufactured: 11/01/2023
• 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; Hospitalization
• Patient Age: 77 YR
• Patient Sex: Male