MAUDE Adverse Event Report: GREATBATCH PLYMOUTH; PACEMAKER LEAD ADAPTOR

Model Number	6986
Medical Device Problem Codes	Signal Artifact/Noise (1036); Low impedance (2285)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this pacemaker system exhibited low out of range impedance measurements and noisy signals for its right ventricular (rv) lead.The rv lead has been in service since 1988.Ts was consulted and recommended further in clinic examination using unipolar setting.This device remains in service.No adverse patient effects were reported.
Additional Manufacturer Narrative
Corrected fields: initial reporter facility name (e1) in section e, initial reporter.
Event or Problem Description
It was reported that this pacemaker system exhibited low out of range impedance measurements and noisy signals for its right ventricular (rv) lead.The rv lead has been in service since 1988.Ts was consulted and recommended further in clinic examination using unipolar setting.This device remains in service.No adverse patient effects were reported.
Event or Problem Description
It was reported that this pacemaker system exhibited low out of range impedance measurements and noisy signals for its right ventricular (rv) lead.The rv lead has been in service since 1988.Ts was consulted and recommended further in clinic examination using unipolar setting.This device remains in service.No adverse patient effects were reported.At a later date, this rv lead was capped and surgically abandoned.A new device was implanted.No additional adverse patient effects were reported.

• Common Device Name: PACEMAKER LEAD ADAPTOR
• 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: 20939534
• Report Number: 2124215-2024-79358
• Device Sequence Number: 4566290
• Product Code: DTD
• UDI-Device Identifier: 00821329900266
• UDI-Public: 00821329900266
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K870562
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/03/2025

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: Lay User/Patient
• Device Expiration Date: 12/01/2024
• Device Model Number: 6986
• Device Catalogue Number: 6986
• Device Lot Number: 321637
• 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: 12/03/2024
• Supplement Date Received by Manufacturer: 01/10/2025; 01/21/2025
• Initial Report FDA Received Date: 12/16/2024
• Supplement Report FDA Received Date: 01/10/2025; 02/03/2025
• Date Device Manufactured: 12/01/2021
• 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: Hospitalization; Required Intervention
• Patient Age: 85 YR
• Patient Sex: Male