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

Model Number V173

Device Problems Pacing Problem (1439); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 09/09/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).The product has been received for analysis.This report would be updated should further information be provided from the analysis.

Event Description

It was reported that this cardiac resynchronization pacemaker (crt-p) was surgically explanted due to pacing not delivered when required.This device was returned for analysis.No additional adverse patient effects were reported.

Manufacturer Narrative

This product was returned and analyzed.The baseline testing completed on the device found no failing conditions.All testing completed on the device passed or was not applicable, therefore no problem was detected.This correction report is being submitted to inform the event is no longer considered reportable as further analysis revealed that the pacing inhibition allegation of this device was incorrect as it was marked incorrectly on the clinical form.This device was explanted due to normal battery depletion (nbd).

Event Description

It was reported that this cardiac resynchronization pacemaker (crt-p) was explanted due to pacing inhibition.Additional information confirmed this was incorrect, this device was explanted due to normal battery depletion.This event is not a complaint as this allegation does not meet reportable complaint criteria.Based on further analysis, it was determined this device did not had the product performance issue of pacing inhibition.Evidence suggest this device was marked with pacing inhibition as an error.The related explanted lead of this procedure, was fractured and it had pacing inhibition.At the end, this device was explanted due to normal battery depletion (nbd), this allegation does not meet complaint criteria.

• Brand Name: INVIVE
• Type of Device: CARDIAC RESYNCHRONIZATION PACEMAKER (CRT-P)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 10714613
• MDR Text Key: 212385531
• Report Number: 2124215-2020-21392
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 00802526536632
• UDI-Public: 00802526536632
• Combination Product (y/n): N
• PMA/PMN Number: P030005/S079
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/18/2020

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 Date: 11/14/2015
• Device Model Number: V173
• Device Catalogue Number: V173
• Device Lot Number: 105008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2020
• Initial Date Manufacturer Received: 09/09/2020
• Initial Date FDA Received: 10/21/2020
• Supplement Dates Manufacturer Received: 12/03/2020
• Supplement Dates FDA Received: 12/19/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 48 YR