MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ALTRUA 60; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

Model Number S602

Device Problems Failure to Capture (1081); Defective Device (2588)

Patient Problems Nausea (1970); Ventricular Tachycardia (2132); Diaphoresis (2452)

Event Date 09/29/2010

Event Type  malfunction  

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

It was reported that this patient with pacemaker device has had runs of ventricular tachycardia (vt) as noted on cardiac event monitor.It was also reported that the device was not pacing.Boston scientific technical services (ts) advised that the device battery might had depleted.Patient advocate was told that the device would reach elective replacement time (ert) in two years.Also, patient advocate stated that the patient had episodes of being diaphoretic and nausea.Technical services then referred the patient to the physician.This device remains in service.No adverse patient effects were reported.

Event Description

It was reported that this patient with pacemaker device has had runs of ventricular tachycardia (vt) as noted on cardiac event monitor.It was also reported that the device was not pacing.Boston scientific technical services (ts) advised that the device battery might had depleted.Patient advocate was told that the device would reach elective replacement time (ert) in two years.Also, patient advocate stated that the patient had episodes of being diaphoretic and nausea.Technical services then referred the patient to the physician.This device remains in service.No adverse patient effects were reported.Additional information indicated that the patient advocate reported non captured spikes on telemetry after colonoscopy.Technical services explained that some functions might be limited after time for replacement.Also, ts discussed device function, magnet response and expected longevity per mag rates.This device remains in service.No adverse patient effects were reported.

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.This supplemental report is being filed to correct adverse event or product problem date of event, initial reporter occupation (other) and all manufacturers report source.

• Brand Name: ALTRUA 60
• Type of Device: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 9270465
• MDR Text Key: 165616816
• Report Number: 2124215-2019-23271
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526484476
• UDI-Public: 00802526484476
• Combination Product (y/n): N
• PMA/PMN Number: N970003/S096
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 04/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/16/2010
• Device Model Number: S602
• Device Catalogue Number: S602
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/11/2020
• Patient Sequence Number: 1
• Patient Age: 77 YR