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

Model Number 4675

Device Problems Device Contamination With Biological Material (2908); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fever (1858); Post Operative Wound Infection (2446)

Event Date 03/15/2018

Event Type  Injury  

Manufacturer Narrative

The product is expected to be returned for analysis.This report will be updated upon return and completion of analysis.

Event Description

Boston scientific received information that the left ventricular (lv) lead was part of system revision due to infection.Reportedly, the patient had fever post implant and was admitted due to wound infection.The patient was given antibiotics.It was also reported that this lv lead had contamination in the electrode end.This lv lead was explanted.There were no additional adverse patient effects reported.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, visual inspection of the lead was performed.Inspection of the lead tip area found a cut which severed the e4 cable and a dried body fluid or blood in the lumen of the tip area was observed.

• Brand Name: ACUITY
• Type of Device: IMPLANTABLE LEAD
• Manufacturer (Section D): CPI - DEL CARIBE; guidant puerto rico b. v.; dorado PR
• Manufacturer (Section G): CPI - DEL CARIBE; guidant puerto rico b. v.; dorado PR
• Manufacturer Contact: tim degroot ; 4100 hamline ave. n; st. paul, MN ; 6515826168
• MDR Report Key: 7443643
• MDR Text Key: 105934826
• Report Number: 2124215-2018-06444
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010012/S398
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/05/2019
• Device Model Number: 4675
• Other Device ID Number: ACUITY X4 SPIRAL S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 04/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 0295; 4470; 4675; G148
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 56 YR