MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION; IMPLANTABLE LEAD

Model Number 4054

Device Problem Connection Problem (2900)

Patient Problem No Code Available (3191)

Event Date 07/17/2020

Event Type  Injury  

Event Description

It was reported that during the change out procedure of this patient's existing pacemaker, the physician had difficulty removing the right ventricular (rv) lead from the header.The physician tried saline, but could not find adequate space to cut back of the header.The physician decided to surgically abandon the pacemaker and both leads and implant a new system on the patients right side.No additional adverse patient effects were reported.

• Type of Device: IMPLANTABLE LEAD
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): CPI - DEL CARIBE; guidant puerto rico b. v.; #12, rd. #698; dorado PR 00646
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 10617993
• MDR Text Key: 209549157
• Report Number: 2124215-2020-16650
• Device Sequence Number: 1
• Product Code: DTB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960006/S001
• 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: 10/01/2020

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: 08/17/2009
• Device Model Number: 4054
• Device Catalogue Number: 4054
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/17/2020
• Initial Date FDA Received: 10/01/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2007
• 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; Required Intervention
• Patient Age: 71 YR