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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INVIVE IMPLANTABLE PACEMAKER

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BOSTON SCIENTIFIC CORPORATION INVIVE IMPLANTABLE PACEMAKER Back to Search Results
Model Number V173
Device Problems Premature Discharge of Battery (1057); Incorrect, Inadequate or Imprecise Resultor Readings (1535); Device Displays Incorrect Message (2591)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Event Date 11/14/2019
Event Type  Injury  
Manufacturer Narrative
The product has been received for analysis. This report will be updated upon completion of analysis.
 
Event Description
It was reported that the cardiac resynchronization therapy pacemaker (crt-p) showed nine months remaining and then two months later showed it was in safety mode. Boston scientific technical services (ts) discussed pacing will remain, but with no left ventricular (lv) offset and both right ventricular (rv) lead and lv are unipolar configuration. The crt-p was explanted and replaced the following day. No additional adverse patient effects were reported.
 
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Brand NameINVIVE
Type of DeviceIMPLANTABLE PACEMAKER
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 Key9550698
MDR Text Key173711338
Report Number2124215-2019-27125
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
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/06/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/05/2014
Device Model NumberV173
Device Catalogue NumberV173
Device Lot Number100394
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/09/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/17/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/27/2012
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: 01/06/2020 Patient Sequence Number: 1
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