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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INVIVE PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)

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BOSTON SCIENTIFIC CORPORATION INVIVE PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P) Back to Search Results
Model Number V173
Device Problem Inappropriate or Unexpected Reset (2959)
Patient Problems No Code Available (3191); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/18/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that this cardiac resynchronization therapy pacemaker (crt-p) reverted to safety mode unexpectedly. Technical services (ts) discussed potential causes and recommended device replacement due to limited therapy available in safety mode. Surgical intervention was undertaken. The device was explanted and replaced. No additional adverse patient effects were reported. The product has been received for analysis. This report will be updated upon completion of analysis.
 
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Brand NameINVIVE
Type of DevicePULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (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 Key10621752
MDR Text Key209640233
Report Number2124215-2020-17959
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
Remedial Action Other
Type of Report Initial,Followup
Report Date 09/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/02/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/01/2015
Device Model NumberV173
Device Catalogue NumberV173
Device Lot Number103885
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/26/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/10/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/03/2013
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: 10/02/2020 Patient Sequence Number: 1
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