MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D

Model Number 4512

Device Problems Fracture (1260); High Capture Threshold (3266)

Patient Problems Device Overstimulation of Tissue (1991); Inadequate Pain Relief (2388)

Event Date 02/08/2021

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that this left ventricular (lv) lead had a revision due to pectoral and inadequate stimulation with high pacing thresholds discovered during a routine follow-up.There was no evidence of noise or fracture at the x-ray test, but when the physician opened the pocket noticed a fracture after the connector so he decided to cut the lead in this point and to connect it by a lead adapter.No asystole recorded.This lead remains in service.No additional adverse patient effects were reported.The complaint lead still remains in service; therefore, no product analysis could be performed.The complaint investigation conclusion code is known inherent risk of device.

• Brand Name: NA
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D
• 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: 11742374
• MDR Text Key: 247921094
• Report Number: 2124215-2021-10621
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P010012/S000
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/28/2006
• Device Model Number: 4512
• Device Catalogue Number: 4512
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/08/2021
• Initial Date FDA Received: 04/28/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2004
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1