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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EMBLEM S-ICD; IMPLANTABLE LEAD
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BOSTON SCIENTIFIC CORPORATION EMBLEM S-ICD; IMPLANTABLE LEAD Back to Search Results
Model Number 3501
Device Problems High impedance (1291); Defective Device (2588); Device Dislodged or Dislocated (2923)
Patient Problems Twiddlers Syndrome (2114); Twiddlers Syndrome (4563)
Event Date 10/22/2020
Event Type  Injury  
Event Description
It was reported that this patient's device had exhibited high impedance (hi) code.The patient was brought into the clinic for imaging and it was determined that the electrode had been severed into three sections that was likely due to twiddler syndrome.This was determined to be the cause of the high impedance code.This electrode was subsequently explanted.No adverse events were reported.
 
Event Description
It was reported that this patient's device had exhibited high impedance (hi) code.The patient was brought into the clinic for imaging and it was determined that the electrode had been severed into three sections that was likely due to twiddler syndrome.This was determined to be the cause of the high impedance code.This electrode was subsequently explanted.No adverse events were reported.This supplemental report is being filled to include device analysis information.
 
Manufacturer Narrative
This lead was thoroughly inspected and analyzed upon receipt at our quality assurance laboratory.Damage to the lead was noted.Due to the location and morphology of damage to the lead it is likely that external stress applied to the lead body resulted in the high out of range shock impedance code.Past experience suggests patient manipulation of the lead through the skin (i.E., twiddler's syndrome) is a contributing factor to damage of this type.
 
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Brand Name
EMBLEM S-ICD
Type of Device
IMPLANTABLE LEAD
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
4100 hamline avenue north
saint paul MN 55112
MDR Report Key11152725
MDR Text Key226235372
Report Number2124215-2020-23108
Device Sequence Number1
Product Code LWS
UDI-Device Identifier00802526599200
UDI-Public00802526599200
Combination Product (y/n)N
PMA/PMN Number
P110042/S077
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 05/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/11/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date07/26/2020
Device Model Number3501
Device Catalogue Number3501
Device Lot Number125263
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/23/2020
Date Manufacturer Received04/09/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Life Threatening; Required Intervention;
Patient Age60 YR
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