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

Model Number V173

Device Problems Signal Artifact/Noise (1036); Over-Sensing (1438); Pacing Problem (1439); Pocket Stimulation (1463); Incorrect, Inadequate or Imprecise Result or Readings (1535); Inappropriate or Unexpected Reset (2959)

Patient Problems Device Overstimulation of Tissue (1991); Presyncope (4410)

Event Date 09/18/2022

Event Type  Injury  

Manufacturer Narrative

The local area field representative was contacted for additional information.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient presented to the emergency room (er) with symptoms of presyncope that she had attributed to her right atrial (ra) and right ventricular (rv) leads.In addition, the patient reported experiencing strong stimulation at the device pocket and in her right arm.Upon interrogation of this cardiac resynchronization therapy pacemaker (crt-p), it was determined that this device had entered safety mode.It was also noted that there was oversensed noise on the leads with pauses of less than two seconds.It was unclear how long the noise had been observed, however overall lead measurements were fairly stable and in range.The patient also reported that "her device was blowing up" and her leads had fractured.Additional information received reported that the right atrial (ra) lead, right ventricular (rv) lead, and crt-p were explanted and replaced.No additional adverse patient effects were reported.

• Brand Name: INVIVE
• Type of Device: PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)
• 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: 15584659
• MDR Text Key: 301545867
• Report Number: 2124215-2022-40964
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 00802526536632
• UDI-Public: 00802526536632
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030005/S079
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 10/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/14/2015
• Device Model Number: V173
• Device Catalogue Number: V173
• Device Lot Number: 103478
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 62 YR
• Patient Sex: Female