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

Model Number V173

Device Problems Premature Discharge of Battery (1057); Pacing Problem (1439); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems Laceration(s) (1946); Syncope/Fainting (4411); Asystole (4442)

Event Date 02/05/2022

Event Type  Injury  

Event Description

It was reported that the patient with this cardiac resynchronization therapy pacemaker (crt-p) presented to the emergency room after experiencing syncope and falling, causing a laceration to their head.It was noted this was due to a 30 second period of asystole.The device was found to be operating in safety mode.The device exhibited brady pacing not delivered when required and premature battery depletion.A temporary pacing wire was placed, then the device was explanted and replaced.No additional adverse patient effects were reported.At this time, the product has not been returned.If the product is returned, analysis will be performed, and this report would be updated at that time.

• Brand Name: INVIVE
• Type of Device: PULSE GENERATOR, 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: 14067539
• MDR Text Key: 289078768
• Report Number: 2124215-2022-05336
• 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: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/24/2014
• Device Model Number: V173
• Device Catalogue Number: V173
• Device Lot Number: 101940
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2012
• 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): Required Intervention; Hospitalization
• Patient Age: 73 YR
• Patient Sex: Female