MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENDOTAK RELIANCE G; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number 0185

Device Problems High impedance (1291); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/06/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that when this patients data was reviewed via remote monitoring a high shock alert was noted by the physician.An in clinic follow up was scheduled.It was noted that the patient had never had any arrhythmias while implanted and did not require bradycardia therapy.It was noted that all other lead parameters were within expected ranges.A review by technical services (ts) noted that the lead trend data showed an increase in shock impedance measurements over the past year.Ts discussed performing an in clinic follow up to perform lead integrity testing, and considering a possible synchronous test shock.Ts note that if shock impedances of a high energy shock are in range, following the patient via remote monitoring was recommended.In additional ts discussed setting up additional alerts to closely monitor the rv lead.No adverse patient effects were reported.Additional information noted that prior to defibrillation testing taking place lead examination did not show any findings or abnormal measurements other then the high out of range shock values.Pocket manipulation was assessed and only when the patient was asked to wave their left arm up and down slight fluctuations and variability was seen on the shock channel.Defibrillation testing then took place and after a 1.1j shock test was attempted normal shock values were seen.Then a 40 j shock took place which showed a normal sinus rhythm after the first shock was delivered, however a yellow warning message was displayed due to an open circuit condition and a shock values > 125 ohms with an error code 1005.The device was then programmed to the previous settings and the lead measurements were taken again.The measurements were in range.A possible connection issue was suspected, but this was not confirmed.A review was sent to technical services.

Manufacturer Narrative

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

Event Description

It was reported that when this patients data was reviewed via remote monitoring a high shock alert was noted by the physician.An in clinic follow up was scheduled.It was noted that the patient had never had any arrhythmias while implanted and did not require bradycardia therapy.It was noted that all other lead parameters were within expected ranges.A review by technical services (ts) noted that the lead trend data showed an increase in shock impedance measurements over the past year.Ts discussed performing an in clinic follow up to perform lead integrity testing, and considering a possible synchronous test shock.Ts note that if shock impedances of a high energy shock are in range, following the patient via remote monitoring was recommended.In additional ts discussed setting up additional alerts to closely monitor the rv lead.No adverse patient effects were reported.Additional information noted that prior to defibrillation testing taking place lead examination did not show any findings or abnormal measurements other then the high out of range shock values.Pocket manipulation was assessed and only when the patient was asked to wave their left arm up and down slight fluctuations and variability was seen on the shock channel.Defibrillation testing then took place and after a 1.1j shock test was attempted normal shock values were seen.Then a 40 j shock took place which showed a normal sinus rhythm after the first shock was delivered, however a yellow warning message was displayed due to an open circuit condition and a shock values > 125 ohms with an error code 1005.The device was then programmed to the previous settings and the lead measurements were taken again.The measurements were in range.A possible connection issue was suspected, but this was not confirmed.A review was sent to technical services.

• Brand Name: ENDOTAK RELIANCE G
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 9550562
• MDR Text Key: 174282687
• Report Number: 2124215-2019-26621
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526531194
• UDI-Public: 00802526531194
• 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: 01/11/2020

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: 03/13/2011
• Device Model Number: 0185
• Device Catalogue Number: 0185
• Device Lot Number: 229820
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/20/2019
• Initial Date FDA Received: 01/06/2020
• Supplement Dates Manufacturer Received: 12/23/2019
• Supplement Dates FDA Received: 01/11/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 35 YR