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

Model Number 7740

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Discharge (2225)

Event Date 02/05/2018

Event Type  Injury  

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 Description

Boston scientific received information that this right atrial (ra) lead was part of a system revision due to infection.Reportedly, the patient's device pocket was leaking.There were no additional adverse patient effects reported.The ra lead was explanted.

• Brand Name: INGEVITY
• 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: 7420632
• MDR Text Key: 105103441
• Report Number: 2124215-2018-02840
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526523427
• UDI-Public: 00802526523427
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150012/S000
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/03/2019
• Device Model Number: 7740
• Other Device ID Number: INGEVITY MRI
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 02/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/03/2017
• 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: 4076; 7740; 7741; ADDR01; L111
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 86 YR