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

Model Number 4097

Device Problems Failure to Capture (1081); Pocket Stimulation (1463); Human-Device Interface Problem (2949)

Patient Problems Muscle Stimulation (1412); Cardiac Perforation (2513); Pericardial Effusion (3271)

Event Date 05/28/2017

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 patient was admitted to the hospital due to diaphragmatic stimulation and complete loss of capture involving their right ventricular (rv) lead.The patient was examined under fluoroscopy and the rv lead was suspected to have perforated the patient.Surgical intervention was performed and the rv lead was repositioned and remains in service.The patient suffered a minimal effusion but this was managed accordingly.No additional adverse patient effects were reported.

• Brand Name: FLEXTEND II
• 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: 6705201
• MDR Text Key: 79744475
• Report Number: 2124215-2017-09727
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): N
• 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: 05/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/15/2018
• Device Model Number: 4097
• Other Device ID Number: FLEXTEND II
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 05/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2016
• 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: 4097; L100
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 61 YR