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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 Problems Premature Discharge of Battery (1057); Incorrect, Inadequate or Imprecise Result or Readings (1535); Battery Problem (2885)
Patient Problems No Code Available (3191); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/18/2020
Event Type  Injury  
Manufacturer Narrative
The device has been received for analysis.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental report will be filed.(b)(4).
 
Event Description
It was reported that this cardiac resynchronization therapy pacemaker (crt-p) reached explant indicator and then went down to end of life (eol) so quickly.The field representative requested for an analysis.The device was explanted.No additional adverse patient effects were reported.
 
Event Description
It was reported that this cardiac resynchronization therapy pacemaker (crt-p) reached explant indicator and then went down to end of life (eol) so quickly.The field representative requested for an analysis.The device was explanted.No additional adverse patient effects were reported.
 
Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, this device was thoroughly inspected and analyzed.Interrogation of the device confirmed it was operating in safety mode due to system resets.Engineers determined that this device was demonstrating behavior consistent with a high internal cell impedance within the battery.The high internal impedance resulted in the system resets due to temporary high-power consumption related to telemetry attempts and subsequent reversion to safety mode operation.Boston scientific has issued a field safety notice regarding ingenio extended life (el) and cardiac resynchronization therapy pacemaker (crt-p) devices that may exhibit this behavior.This particular device is included in the high impedance in ingenio extended life (el) pacemaker and crt-p advisory population.
 
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Brand Name
INVIVE
Type of Device
PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
4100 hamline avenue north
saint paul MN 55112
MDR Report Key10744250
MDR Text Key213396897
Report Number2124215-2020-21991
Device Sequence Number1
Product Code NKE
UDI-Device Identifier00802526536632
UDI-Public00802526536632
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 08/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date06/19/2015
Device Model NumberV173
Device Catalogue NumberV173
Device Lot Number103790
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/13/2020
Initial Date Manufacturer Received 09/18/2020
Initial Date FDA Received10/27/2020
Supplement Dates Manufacturer Received04/16/2021
Supplement Dates FDA Received08/03/2021
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberZ-2016-2021
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age67 YR
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