MAUDE Adverse Event Report: CPI - DEL CARIBE ACUITY; IMPLANTABLE HF LEADS

Model Number	4593
Medical Device Problem Codes	Fracture (1260); High impedance (1291); Capturing Problem (2891)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/01/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A boston scientific technical services consultant documented and discussed the clinical observations with the caller.The caller stated that this patient's physician was going to be bringing this patient in for an x-ray.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 elevated threshold measurements and elevated pacing impedance measurements on the left ventricular (lv) channel.It was noted that impedance measurements had exceeded 2500 ohms.No adverse patient effects were reported.
Additional Manufacturer Narrative
A revision procedure was subsequently performed and lead and the associated device were removed from service and replaced.A fracture of this lead was suspected but has not been 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: ACUITY
• Common Device Name: IMPLANTABLE HF LEADS
• Manufacturer (Section D): CPI - DEL CARIBE; guidant puerto rico b. v.; dorado PR
• MDR Report Key: 6935590
• Report Number: 2124215-2017-18255
• Device Sequence Number: 1325051
• Product Code: LWP
• UDI-Device Identifier: 00802526423222
• UDI-Public: 00802526423222
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2017

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: 12/12/2014
• Device Model Number: 4593
• Other Device ID Number: ACUITY SPIRAL
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 09/21/2017
• Supplement Date Received by Manufacturer: 10/17/2017
• Initial Report FDA Received Date: 10/10/2017
• Supplement Report FDA Received Date: 01/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 84 YR