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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ORIGEN X4 CRT-D; CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D)
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BOSTON SCIENTIFIC CORPORATION ORIGEN X4 CRT-D; CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) Back to Search Results
Model Number G058
Device Problems Signal Artifact/Noise (1036); High impedance (1291); High Capture Threshold (3266); Noise, Audible (3273)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/19/2022
Event Type  Injury  
Event Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) system exhibited high out of range pacing impedance in the right ventricular (rv) and left ventricular (lv) leads.The device was also noted to exhibit beeping tones.The leads were measured with the pacing system analyzer (psa) and the lv lead measurements were noted to be in range.The rv lead measurements continued to be high and high threshold was also noted.It was mentioned that the rv lead could exhibit a lead conductor fracture or an insulation damage, and noise was also observed in this lead.Subsequently, the crt-d and rv lead were replaced and the new measurements after the products replacement were within adequate range.The lv lead remains in service.No additional adverse patient effects.The crt-d device is expected to be returned for analysis.Additional information indicates the crt-d device was replaced to be on the safe side due to the high out of range impedance measurements and the beeping tones observed were also caused by the high impedance measurements.In addition, the lv lead high out of range impedance is believed to be due to the stimulation being set against the rv lead.
 
Manufacturer Narrative
The returned device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.<
 
Event Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) system exhibited high out of range pacing impedance in the right ventricular (rv) and left ventricular (lv) leads.The device was also noted to exhibit beeping tones.The leads were measured with the pacing system analyzer (psa) and the lv lead measurements were noted to be in range.The rv lead measurements continued to be high and high threshold was also noted.It was mentioned that the rv lead could exhibit a lead conductor fracture or an insulation damage, and noise was also observed in this lead.Subsequently, the crt-d and rv lead were replaced and the new measurements after the products replacement were within adequate range.The lv lead remains in service.No additional adverse patient effects.The crt-d device is expected to be returned for analysis.Additional information indicates the crt-d device was replaced to be on the safe side due to the high out of range impedance measurements and the beeping tones observed were also caused by the high impedance measurements.In addition, the lv lead high out of range impedance is believed to be due to the stimulation being set against the rv lead.The device was returned for analysis.
 
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Brand Name
ORIGEN X4 CRT-D
Type of Device
CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D)
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 Key14640120
MDR Text Key293623322
Report Number2124215-2022-20291
Device Sequence Number1
Product Code NIK
UDI-Device Identifier00802526534515
UDI-Public00802526534515
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
P010012/S341
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 08/10/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/08/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date05/19/2019
Device Model NumberG058
Device Catalogue NumberG058
Device Lot Number171667
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/09/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/06/2017
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age56 YR
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