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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ACCOLADE MRI SR; IMPLANTABLE DEVICE

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BOSTON SCIENTIFIC CORPORATION ACCOLADE MRI SR; IMPLANTABLE DEVICE Back to Search Results
Model Number L310
Device Problems Defective Device (2588); Contamination /Decontamination Problem (2895)
Patient Problems No Code Available (3191); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/23/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that this device was explanted after 8 months of being implanted.The non-bsc right ventricular (rv) lead was surgically abandoned.No additional adverse patient effects were reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that this device was explanted after 8 months of being implanted.During the rv lead revision the pacemaker was accidentally touched by one of the nurses that was not scrubbed into the case, thus rendering it unsterile.Non-bsc right ventricular (rv) lead was surgically abandoned.No additional adverse patient effects were reported.
 
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Brand Name
ACCOLADE MRI SR
Type of Device
IMPLANTABLE DEVICE
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
4100 hamline avenue north
saint paul MN 55112
MDR Report Key11206841
MDR Text Key227918030
Report Number2124215-2021-00965
Device Sequence Number1
Product Code LWP
UDI-Device Identifier00802526559204
UDI-Public00802526559204
Combination Product (y/n)N
PMA/PMN Number
P150012/S000
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 02/22/2021
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 Date12/06/2021
Device Model NumberL310
Device Catalogue NumberL310
Device Lot Number804109
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/23/2020
Initial Date FDA Received01/21/2021
Supplement Dates Manufacturer Received01/20/2021
Supplement Dates FDA Received02/22/2021
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age22 YR
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