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

Model Number 7740

Device Problem Human-Device Interface Problem (2949)

Patient Problem Atrial Perforation (2511)

Event Date 06/13/2018

Event Type  Injury  

Manufacturer Narrative

At this time, the lead remains implanted.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 perforated the patient's heart wall as confirmed via chest x-ray.As result, a pericardiocentesis was performed to treat the perforation.The ra lead remains in service.No additional adverse patient effects were reported.

• 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: 7696275
• MDR Text Key: 114276023
• Report Number: 2124215-2018-12380
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/13/2018

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/11/2020
• Device Model Number: 7740
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 06/13/2018
• Initial Date FDA Received: 07/17/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2018
• 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
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 77 YR