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

Model Number 7741

Device Problems Capturing Problem (2891); Human-Device Interface Problem (2949)

Patient Problems Bradycardia (1751); Respiratory Failure (2484); Cardiac Perforation (2513)

Event Date 01/27/2018

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, during the implant procedure of this right ventricular (rv) lead, the patient's oxygen saturation level decreased.It was suspected this rv lead perforated the heart wall.Pericardiocentesis was performed with fluid removal.There were no pauses in pacing of greater than 2 seconds.The pacing thresholds were low, but the rv lead was still able to pace and capture.The oxygen saturation levels continued to decrease, so the patient was intubated and administered epinephrine.It was noted the patient's underlying rhythm was between 33-34 beats per minute.This rv lead was explanted and a new rv lead was implanted.No additional adverse patient effects were reported.This lead will not be returned.Following the implant procedure, the patient was awake and responding to commands.

• 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: 7353853
• MDR Text Key: 102924894
• Report Number: 2124215-2018-03627
• 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: 01/27/2018

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: Health Professional
• Device Expiration Date: 01/13/2020
• Device Model Number: 7741
• Other Device ID Number: INGEVITY MRI
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 01/27/2018
• Initial Date FDA Received: 03/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2018
• 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
• Treatment: 7740; 7741; L331
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 81 YR