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

Model Number 0148

Device Problems High impedance (1291); Data Problem (3196); High Capture Threshold (3266)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/01/2023

Event Type  malfunction  

Manufacturer Narrative

No additional information is available.If additional information becomes available the report will be updated at that time.

Event Description

It was reported that the right ventricular (rv) lead exhibited high out of range pacing impedance measurements of greater than 2000 ohms along with increasing threshold measurements.The patient underwent provocation maneuvers and no oversensing or noise was observed.It was believed that the change in values is due to the age of the lead as it has been implanted for 24 years.The output was increased to maximum value.Data was sent into technical services (ts) for review.Upon review ts noted that the increase in impedance measurement has been gradual.Ts discussed higher thresholds need to be evaluated for appropriate programming of outputs to ensure appropriate capture.Ts indicated that this could be a symptom of encapsulation or ionization, but further testing would need to occur.No noise episodes have been stored, however ts observed greater than three thousand counters that were greater than 250 minutes during a six-month time frame.Ts discussed troubleshooting the lead to determine the reason for the high counters.The rv lead remains in service and no adverse effects were reported.

• Brand Name: ENDOTAK RELIANCE
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): CPI - DEL CARIBE; guidant puerto rico b. v.; #12, rd. #698; dorado PR 00646
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 18923301
• MDR Text Key: 337894151
• Report Number: 2124215-2024-16122
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): Y
• Reporter Country Code: SM
• PMA/PMN Number: P910073/S032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/01/2002
• Device Model Number: 0148
• Device Catalogue Number: 0148
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2000
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1