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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPORATION VISIONIST CRT-P; PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P) Back to Search Results
Model Number U225
Device Problems Difficult to Insert (1316); Material Integrity Problem (2978)
Patient Problems No Code Available (3191); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/09/2020
Event Type  malfunction  
Event Description
It was reported that during a box change procedure, this cardiac resynchronization therapy pacemaker (crt-p) was an attempted implant.The physician was unable to connect the right atrial (ra) lead into the ra port.It was not possible to advance the lead three-quarters of the way into the port, therefore the lead tip did not reach the set screw.The lead was able to be inserted and connected onto the right ventricular port.This device was replaced and the second device did not encountered any header issues.No adverse patient effects were reported.
 
Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, under-insertion of the lead terminal pin into the device header was suspected to be the cause of the insertion difficulty but this could not be confirmed during laboratory analysis.Note that boston scientific has a vigilant quality monitoring system and we aggressively monitor field performance of all our products.We will continue to monitor for similar events.
 
Event Description
It was reported that during a box change procedure, this cardiac resynchronization therapy pacemaker (crt-p) was an attempted implant.The physician was unable to connect the right atrial (ra) lead into the ra port.It was not possible to advance the lead three-quarters of the way into the port, therefore the lead tip did not reach the set screw.The lead was able to be inserted and connected onto the right ventricular port.This device was replaced and the second device did not encountered any header issues.No adverse patient effects were reported.
 
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Brand Name
VISIONIST CRT-P
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 Key11220874
MDR Text Key258431853
Report Number2124215-2021-01675
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
PMA/PMN Number
P030005/S138
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 10/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/02/2022
Device Model NumberU225
Device Catalogue NumberU225
Device Lot Number716876
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/14/2021
Initial Date Manufacturer Received 12/16/2020
Initial Date FDA Received01/24/2021
Supplement Dates Manufacturer Received09/02/2021
Supplement Dates FDA Received10/10/2021
Patient Sequence Number1
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