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

Model Number P163

Device Problems High impedance (1291); Incorrect, Inadequate or Imprecise Result or Readings (1535); Inappropriate/Inadequate Shock/Stimulation (1574); Failure to Read Input Signal (1581)

Patient Problem Electric Shock (2554)

Event Date 12/01/2022

Event Type  Injury  

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) recorded a code 1005, indicating an open circuit condition.Inappropriate shocks for fast conducted atrial fibrillation (af) were also reported.The patient was admitted to the hospital with therapies turned off, pending data analysis by technical services.Data analysis confirmed the right ventricular (rv) shock impedance has been high and out-of-range for approximately one month.A single low, out-of-range r-wave intrinsic amplitude measurement was also noted.Technical services recommended evaluation of the pulse generator and lead system integrity.No additional adverse patient effects were reported.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) recorded a code 1005, indicating an open circuit condition.Inappropriate shocks for fast conducted atrial fibrillation (af) were also reported.The patient was admitted to the hospital with therapies turned off, pending data analysis by technical services.Data analysis confirmed the right ventricular (rv) shock impedance has been high and out-of-range for approximately one month.A single low, out-of-range r-wave intrinsic amplitude measurement was also noted.Technical services recommended evaluation of the pulse generator and lead system integrity.No additional adverse patient effects were reported.Additional information received indicates the patient elected to have tachy therapy turned off following the shocks.The patient was sent back to (b)(6) hospital for follow-up, and their device will likely be monitored as though it were a crt-p.

Manufacturer Narrative

This device remains implanted; therefore, technical analysis cannot be conducted.Without a returned device it is not possible to definitively confirm how the device may have contributed to the complaint incident.If information is provided in the future, a supplemental report will be issued.

• Brand Name: INCEPTA CRT-D
• Type of Device: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 15925794
• MDR Text Key: 304915832
• Report Number: 2124215-2022-51001
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/17/2023

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: 05/13/2015
• Device Model Number: P163
• Device Catalogue Number: P163
• Device Lot Number: 109935
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2022
• Initial Date FDA Received: 12/06/2022
• Supplement Dates Manufacturer Received: 02/17/2023
• Supplement Dates FDA Received: 02/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Hospitalization
• Patient Age: 75 YR
• Patient Sex: Male