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

Model Number	4593
Medical Device Problem Codes	Extracardiac stimulation (1463); Capturing Problem (2891); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Codes	Muscle Stimulation (1412); No Known Impact Or Consequence To Patient (2692)
Date of Event	07/10/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time, the product has not been returned.If the product is returned, analysis will be performed and this report would be updated at that time.
Event or Problem Description
Boston scientific received information that this left ventricular (lv) lead was abandoned surgically for an unknown issue.No further information is known, at this time.No additional adverse patient effects were reported.
Event or Problem Description
Additional information indicated that high pacing thresholds were observed with this lv lead.Thresholds were reportedly higher than diaphragmatic stimulation threshold.This lv lead was abandoned surgically.No additional adverse patient effects were reported.

• 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: 7190319
• Report Number: 2124215-2017-19328
• Device Sequence Number: 10802652
• Product Code: LWP
• UDI-Device Identifier: 00802526423222
• UDI-Public: 00802526423222
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2017

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: 11/20/2014
• 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: 10/10/2017
• Supplement Date Received by Manufacturer: 10/10/2017
• Initial Report FDA Received Date: 01/15/2018
• 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: 83 YR