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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 Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/15/2021
Event Type  Injury  
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.
 
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.
 
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.
 
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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 Key12243179
MDR Text Key264041759
Report Number2124215-2021-21351
Device Sequence Number1
Product Code NKE
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,health
Type of Report Initial,Followup
Report Date 10/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/28/2021
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
Date Manufacturer Received08/24/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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