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

Model Number G179

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Twiddlers Syndrome (2114)

Event Date 12/21/2018

Event Type  Injury  

Manufacturer Narrative

This investigation is ongoing.Upon further information this investigation will be updated.

Event Description

It was reported that an alert was received via the remote monitoring system indicating anti-tachycardia pacing (atp) had been delivered.Review of the event found evidence of oversensing on the right atrial right ventricular (rv) and left ventricular (lv) leads.Some changes in impedance measurements were also noted in the preceding months, though no out-of-range measurements were reported.Upon presentation to clinic for review, all leads demonstrated atrial sensing in addition to loss of capture.An x-ray was performed confirming all leads had dislodged as a result of the patient twiddling their device.All therapy was programmed as the patient is not pacemaker dependent.A revision procedure is planned in the coming weeks.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.

Event Description

It was reported that an alert was received via the remote monitoring system indicating anti-tachycardia pacing (atp) had been delivered.Review of the event found evidence of oversensing on the right atrial right ventricular (rv) and left ventricular (lv) leads.Some changes in impedance measurements were also noted in the preceding months, though no out-of-range measurements were reported.Upon presentation to clinic for review, all leads demonstrated atrial sensing in addition to loss of capture.An x-ray was performed confirming all leads had dislodged as a result of the patient twiddling their device.All therapy was programmed as the patient is not pacemaker dependent.A revision procedure was later performed during which the chronic leads were explanted and replaced; the device was reimplanted subpectorally and sutured in place.The leads were not made available for return following the procedure.No additional adverse patient effects were reported.

• Brand Name: AUTOGEN
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 8300232
• MDR Text Key: 134864225
• Report Number: 2124215-2019-01564
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 04/15/2019

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: 05/11/2018
• Device Model Number: G179
• Device Catalogue Number: G179
• Device Lot Number: 150419
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/21/2018
• Initial Date FDA Received: 02/02/2019
• Supplement Dates Manufacturer Received: 02/14/2019
• Supplement Dates FDA Received: 04/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention