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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INVIVE PULSE GENERATOR, (CRT-P)

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BOSTON SCIENTIFIC CORPORATION INVIVE PULSE GENERATOR, (CRT-P) Back to Search Results
Model Number V173
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problems No Code Available (3191); Insufficient Information (4580)
Event Date 12/22/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4). This device has been returned for analysis. This report will be updated upon completion of analysis.
 
Event Description
It was reported that this cardiac resynchronization therapy pacemaker (crt-p) was found to be operating in safety mode. The device was interrogated just prior to explant, and was noted to have recorded a code 1007, indicative of capacitor charge time has exceeded the limit. The device was explanted and replaced. No additional adverse patient effects were reported.
 
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Brand NameINVIVE
Type of DevicePULSE GENERATOR, (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 Key11211821
MDR Text Key228163278
Report Number2124215-2021-01172
Device Sequence Number1
Product Code NKE
UDI-Device Identifier00802526536632
UDI-Public00802526536632
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 06/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/21/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/03/2014
Device Model NumberV173
Device Catalogue NumberV173
Device Lot Number102363
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/11/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/16/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/07/2012
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/21/2021 Patient Sequence Number: 1
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