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

Model Number	4593
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Sepsis (2067); Swelling (2091)
Date of Event	03/05/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 cleft ventricular (lv) lead was part of a system revision due to infection with sepsis.The patient advocate reportedly stated that there was swelling after the new device was implanted.There were no additional adverse patient effects reported.The lv lead was explanted.
Event or Problem Description
Boston scientific received information that this left ventricular (lv) lead was part of a system revision due to infection with sepsis.The patient advocate reportedly stated that there was swelling after the new device was implanted.There were no additional adverse patient effects reported.The lv lead was explanted.

• 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: 6556409
• Report Number: 2124215-2017-08134
• Device Sequence Number: 10916528
• Product Code: LWP
• UDI-Device Identifier: 00802526423222
• UDI-Public: (01)00802526423222(17)20131128
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P010012/S160
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2017

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 11/28/2013
• 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: 03/05/2017
• Supplement Date Received by Manufacturer: 05/02/2017
• Initial Report FDA Received Date: 05/10/2017
• Supplement Report FDA Received Date: 07/07/2017
• 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: 0293; 4470; 4593; G150; N160
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 58 YR