MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INVIVE; PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)

Model Number V173

Device Problem Pacing Intermittently (1443)

Patient Problem No Code Available (3191)

Event Date 07/20/2020

Event Type  malfunction  

Event Description

Incident description: per physician: patient device near elective replacement indicator (eri).Received unusual fault code and went into safety mode.Patient was experiencing 12 second pauses, and only being paced intermittently.Device replaced with a new device.From the ep procedural note: indication: the patient elderly presented with preexisting pacemaker placed ~6 years ago, with device approaching elective replacement indicator, but tripped to a 'fault' mode premature with failure to stimulate and resultant pauses of 12 seconds.The patient underwent biventricular pacemaker generator change.There were no complications.Equipment specifics: right atrial lead: manufacturer: guidant, model #: 4470-52, location: right atrium , fixation: active, sensing: 1.8 mv, threshold: fibrillation, impedance: 380 ohms.Right ventricular lead: manufacturer: guidant, model #: 4088-59, location: right ventricle, fixation: active, sensing: 4.1 mv, threshold: 1.1 v @ 0.4 msec, impedance: 580 ohms.Left ventricular lead: manufacturer: guidant, model #: easytrak 2-80, location: left ventricle , fixation: passive, sensing: 15.0 mv, threshold: 2.2 v @ 1.5 msec, impedance: 613 ohms.Explanted generator: manufacturer: boston scientific, model #: v173, final settings mode: vvir, lower rate: 70, upper rate: 120, right atrial output right ventricular output 2.5 v @ 0.4 ms, left ventricular output 3.2 v @ 0.4 ms.Impression: atrioventricular block, history of cardiomyopathy.Permanent atrial fibrillation.Device replaced because of 'fault' mode, prior to elective replacement indicator biventricular pacemaker generator change.

• Brand Name: INVIVE
• Type of Device: PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10400948
• MDR Text Key: 202706187
• Report Number: 10400948
• Device Sequence Number: 1
• Product Code: NKE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: V173
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/06/2020
• Device Age: 6 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 29565 DA
• Patient Weight: 116