MAUDE Adverse Event Report: CPI - DEL CARIBE FINELINE II; IMPLANTABLE LEAD

Model Number	4458
Medical Device Problem Codes	Failure to Capture (1081); High impedance (1291); Over-Sensing (1438); Ambient Noise Problem (2877)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/26/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A boston scientific technical services consultant documented and discussed the clinical observations with the caller who stated a revision procedure will be performed in the near future.All products remain in service at this time.The root cause of the reported clinical observations was not identified and efforts to obtain additional product issue details were unsuccessful.As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.
Event or Problem Description
Boston scientific received information that this system exhibited a pacing impedance measurement greater than 2500 ohms on the right ventricular (rv) channel which had triggered the lead safety switch (lss).Additionally, capture issues were noted and there were stored episodes of noise which had been oversensed.No adverse patient effects were reported.
Additional Manufacturer Narrative
Additional information was received confirming that a revision procedure was performed.The lead was visualized under fluoroscopy and no conclusive evidence of a lead fracture was observed.The lead was removed from service and the replacement lead was successfully interfaced to the chronic device and normal function was confirmed.As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.

• Brand Name: FINELINE II
• Common Device Name: IMPLANTABLE LEAD
• Manufacturer (Section D): CPI - DEL CARIBE; guidant puerto rico b. v.; dorado PR
• MDR Report Key: 6696666
• Report Number: 2124215-2017-08073
• Device Sequence Number: 1772866
• Product Code: DTB
• UDI-Device Identifier: 00802526060953
• UDI-Public: (01)00802526060953(17)20111123
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2017

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: 11/23/2011
• Device Model Number: 4458
• Other Device ID Number: FINELINE II STEROX
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 04/04/2017
• Supplement Date Received by Manufacturer: 05/18/2017
• Initial Report FDA Received Date: 07/10/2017
• Supplement Report FDA Received Date: 07/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 4135; 4458; S606
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 74 YR