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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INVIVE; IMPLANTABLE DEVICE
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BOSTON SCIENTIFIC CORPORATION INVIVE; IMPLANTABLE DEVICE Back to Search Results
Model Number V173
Device Problems Over-Sensing (1438); Pacing Problem (1439); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problems Asystole (4442); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/12/2021
Event Type  Injury  
Event Description
It was reported that the cardiac resynchronization therapy pacemaker (crt-p) was found to be in safety mode.A device replacement had been scheduled; however, the patient was placed in hospice.The crt-p remains in service.
 
Event Description
It was reported that the cardiac resynchronization therapy pacemaker (crt-p) was found to be in safety mode.A device replacement had been scheduled; however, the patient was placed in hospice.The crt-p remains in service.It was additionally reported that the patient had been admitted to the hospital due to the safety mode.The crt-p exhibited oversensing with pacing inhibition of greater than two seconds.The physician elected to externally pace the patient.The patient was moved to palliative care and it was decided to leave the crt-p implanted.No additional adverse patient effects were reported.
 
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Brand Name
INVIVE
Type of Device
IMPLANTABLE DEVICE
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
4100 hamline avenue north
saint paul MN 55112
MDR Report Key12114224
MDR Text Key260029806
Report Number2124215-2021-17503
Device Sequence Number1
Product Code NKE
UDI-Device Identifier00802526536632
UDI-Public00802526536632
Combination Product (y/n)N
PMA/PMN Number
P030005/S079
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Type of Report Initial,Followup
Report Date 08/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/04/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date01/07/2015
Device Model NumberV173
Device Catalogue NumberV173
Device Lot Number102771
Was Device Available for Evaluation? No
Date Manufacturer Received06/23/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age74 YR
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