MAUDE Adverse Event Report: GREATBATCH PLYMOUTH; IMPLANTABLE LEAD

Model Number	4047
Medical Device Problem Codes	Signal Artifact/Noise (1036); High impedance (1291); Over-Sensing (1438); Pacing Problem (1439)
Health Effect - Clinical Code	Asystole (4442)
Date of Event	01/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this cardiac resynchronization therapy pacemaker (crt-p) triggered a lead safety switch (lss) due to pacing impedance measurements out of range on the right ventricular (rv) lead.Technical services (ts) reviewed and provided troubleshooting options.This patient was seen in clinic and noise oversensing was noted, as well as pacing inhibition greater than two seconds.Ts stated this is likely related to a lead anomaly.Ts suggested to have the patient performed a patient-initiated interrogation (pii) until schedule for a replacement.This lead remains in service.No adverse patient effects were reported.
Additional Manufacturer Narrative
If pertinent information is provided in the future, a supplemental report will be submitted.
Additional Manufacturer Narrative
This report is being filed to correct the original initial report that was filed in error as this is not a boston scientific product and boston scientific does not have reportability responsibility.If pertinent information is provided in the future, a supplemental report will be submitted.
Event or Problem Description
It was reported that this cardiac resynchronization therapy pacemaker (crt-p) triggered a lead safety switch (lss) due to pacing impedance measurements out of range on the right ventricular (rv) lead.Technical services (ts) reviewed and provided troubleshooting options.This patient was seen in clinic and noise oversensing was noted, as well as pacing inhibition greater than two seconds.Ts stated this is likely related to a lead anomaly.Ts suggested to have the patient performed a patient-initiated interrogation (pii) until schedule for a replacement.This lead remains in service.No adverse patient effects were reported.
Additional Manufacturer Narrative
This product remains implanted and in-service.As such, physical analysis has not been conducted in our laboratory.Based on the available information, and in the absence of a product return, boston scientific has assigned an investigation conclusion code of cause not established.A review of the device history record (dhr) was performed.The review of the dhr identified that there were no process related non-conformances, scrap, or rework performed during the production that could explain the event.The reviews ensure each device meets specification prior to release for use.There is no indication the device manufacturing process contributed to the reported complaint.If pertinent information is provided in the future, a supplemental report will be submitted.
Event or Problem Description
It was reported that this cardiac resynchronization therapy pacemaker (crt-p) triggered a lead safety switch (lss) due to pacing impedance measurements out of range on the right ventricular (rv) lead.Technical services (ts) reviewed and provided troubleshooting options.This patient was seen in clinic and noise oversensing was noted, as well as pacing inhibition greater than two seconds.Ts stated this is likely related to a lead anomaly.Ts suggested to have the patient performed a patient-initiated interrogation (pii) until schedule for a replacement.This lead remains in service.No adverse patient effects were reported.

• 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 ; 6515826168
• MDR Report Key: 24210066
• Report Number: 2124215-2026-05239
• Device Sequence Number: 9635738
• Product Code: DTB
• UDI-Device Identifier: 00821329900228
• UDI-Public: (01)00821329900228(11)220401(17)250401
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/14/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/01/2025
• Device Model Number: 4047
• Device Catalogue Number: 4047
• Device Lot Number: 329808
• 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: 01/12/2026
• Supplement Date Received by Manufacturer: 02/01/2026; 03/23/2026
• Initial Report FDA Received Date: 01/29/2026
• Supplement Report FDA Received Date: 02/11/2026; 04/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/01/2022
• 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
• Patient Age: 80 YR
• Patient Sex: Male