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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION COGNIS; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
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BOSTON SCIENTIFIC CORPORATION COGNIS; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) Back to Search Results
Model Number N119
Device Problems Use of Device Problem (1670); Interrogation Problem (4017)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/12/2020
Event Type  Injury  
Manufacturer Narrative
As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.
 
Event Description
It was reported that attempts to communicate with this device were unsuccessful and interrogation could not be obtained despite multiple troubleshooting efforts.It was confirmed that successful communication was obtained with other devices on the same day.Additionally, magnet application did not elicit any tones.The patient was sent home with a life vest until device replacement can occur.No adverse patient effects were reported.
 
Manufacturer Narrative
This product is being evaluated in our post market quality assurance laboratory.This report will be updated when evaluation is complete.
 
Event Description
It was reported that this device was subsequently explanted and returned for testing.No additional adverse patient effects were reported.
 
Event Description
It was reported that attempts to communicate with this device were unsuccessful and interrogation could not be obtained despite multiple troubleshooting efforts.It was confirmed that successful communication was obtained with other devices on the same day.Additionally, magnet application did not elicit any tones.The patient was sent home with a life vest until device replacement can occur.No adverse patient effects were reported.It was reported that this device was subsequently explanted and returned for testing.No additional adverse patient effects were reported.
 
Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, visual inspection of the device identified no anomalies.The device could not be interrogated.An x-ray of the device revealed that the internal high voltage fuse was damaged (i.E., no longer intact).As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.
 
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Brand Name
COGNIS
Type of Device
IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
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 Key10653789
MDR Text Key210621752
Report Number2124215-2020-20279
Device Sequence Number1
Product Code LWP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P010012/S165
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 05/21/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/08/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date10/20/2011
Device Model NumberN119
Device Catalogue NumberN119
Device Lot Number145587
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/02/2020
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/05/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/22/2010
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Life Threatening; Hospitalization; Required Intervention;
Patient Age62 YR
Patient SexMale
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