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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INVIVE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P)

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BOSTON SCIENTIFIC CORPORATION INVIVE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) Back to Search Results
Model Number V173
Device Problems Signal Artifact/Noise (1036); Over-Sensing (1438); Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/14/2021
Event Type  Injury  
Manufacturer Narrative
The product has been received for analysis. This report will be updated upon completion of analysis, should pertinent information be provided.
 
Event Description
It was reported that this cardiac resynchronization therapy pacemaker (crt-p) entered into safety mode and it was promptly scheduled for replacement. The patient was seen in clinic and upon device interrogation, it was noted that the left ventricular (lv) lead exhibited noise and oversensing due to myopotentials when the patient moved the arm. Reportedly, the noise and oversensing were caused by the lv lead being automatically reprogrammed due to the crt-p entering into safety mode. Subsequently, this crt-p was successfully implanted and replaced on that same day. No additional adverse patient effects. The product was returned for analysis.
 
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Brand NameINVIVE
Type of DeviceCARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (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 Key12620062
MDR Text Key276367213
Report Number2124215-2021-24320
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 health professional
Reporter Occupation Other Health Care Professional
Remedial Action Recall
Type of Report Initial,Followup
Report Date 10/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/12/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/30/2015
Device Model NumberV173
Device Catalogue NumberV173
Device Lot Number104147
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/27/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/24/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/02/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/12/2021 Patient Sequence Number: 1
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