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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 Incorrect, Inadequate or Imprecise Result or Readings (1535); Unexpected Therapeutic Results (1631)
Patient Problem Insufficient Information (4580)
Event Date 04/15/2021
Event Type  Injury  
Manufacturer Narrative
This product has not been returned for analysis.This report will be updated should additional information become available or if analysis is completed.
 
Event Description
It was reported that on three devices safety mode was triggered within the last year to six months of battery life.Two were replaced without incident.The third was also replaced, but the patient presented with syncope and recurrent failure to output therapy was observed, requiring transcutaneous pacing.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
Manufacturer Contact
timothy degroot
4100 hamline avenue north
saint paul, MN 55112
6515826168
MDR Report Key12243161
MDR Text Key264041993
Report Number2124215-2021-21349
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P030005/S079
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/28/2021
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 Model NumberV173
Device Catalogue NumberV173
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/20/2021
Initial Date FDA Received07/28/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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