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

Model Number H175

Device Problems Signal Artifact/Noise (1036); Premature Discharge of Battery (1057); Over-Sensing (1438); Pacing Problem (1439); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Stroke/CVA (1770); Electric Shock (2554)

Event Date 08/01/2013

Event Type  Injury  

Event Description

Per literature review article "use caution when applying magnets to pacemakers or defibrillators for surgery" schulman, peter., et al., it was reported that a patient with a cardiac resynchronization therapy defibrillator (crt-d) underwent elective operative thoracoabdominal aortic aneurysm repair.It was noted that the device was not evaluated preoperatively.During the procedure, a magnet was placed over the device to prevent tachycardia therapy; however, shocks were observed.The magnet was repositioned due to the belief that the magnet had moved.A postoperative device check revealed greater than 20 shocks and 12 anti-tachycardia pacing (atp) events for electrical noise and oversensing.It was noted that the operative team was not aware that due to a prior product advisory, this device had a disabled magnet switch.The tachycardia therapy resulted in premature battery depletion requiring device replacement.The patient also experienced a perioperative cerebrovascular accident.No additional adverse patient effects were reported.The status of the device was unknown.Attempts were made to obtain additional information; however, no additional information was provided.

• 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): BOSTON SCIENTIFIC
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 15150348
• MDR Text Key: 297129460
• Report Number: 2124215-2022-28658
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010012/S008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/02/2022

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 Model Number: H175
• Device Catalogue Number: H175
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/18/2022
• Initial Date FDA Received: 08/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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