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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENDOTAK RELIANCE; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
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BOSTON SCIENTIFIC CORPORATION ENDOTAK RELIANCE; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) Back to Search Results
Model Number 0161
Device Problems High impedance (1291); Defibrillation/Stimulation Problem (1573)
Patient Problems Ventricular Tachycardia (2132); No Code Available (3191); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/18/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that this patient experienced ventricular fibrillation (vf) which was treated appropriately with a shock and was successfully converted back to a normal rhythm.However, shortly after this vf episode, the patient experienced ventricular tachycardia (vt) and was appropriately treated with seven shocks to end the vt episode.Device interrogation revealed a code 1005, indicating an open circuit condition.Boston scientific technical services was contacted and it was noted that during the shock deliveries, there were multiple high, out of range (>125 ohms) shock impedance measurements from this right ventricular (rv) lead.Rv lead replacement was recommended to resolve the event.The physician elected to surgically explant and replace this rv lead.During the procedure, damage was seen to the device setscrew and the physician elected to also explant and replace the device to resolve the event.The patient was stable with no additional adverse consequences.This rv lead is expected for analysis, but has not yet been received.
 
Event Description
It was reported that this patient experienced ventricular fibrillation (vf) which was treated appropriately with a shock and was successfully converted back to a normal rhythm.However, shortly after this vf episode, the patient experienced ventricular tachycardia (vt) and was appropriately treated with seven shocks to end the vt episode.Device interrogation revealed a code 1005, indicating an open circuit condition.Boston scientific technical services was contacted and it was noted that during the shock deliveries, there were multiple high, out of range (>125 ohms) shock impedance measurements from this right ventricular (rv) lead.Rv lead replacement was recommended to resolve the event.The physician elected to surgically explant and replace this rv lead.During the procedure, damage was seen to the device setscrew and the physician elected to also explant and replace the device to resolve the event.The patient was stable with no additional adverse consequences.This rv lead is expected for analysis, but has not yet been received.
 
Manufacturer Narrative
Patient code 3191 captures the reportable event of surgery.This correction report is being sent to include the explant date.
 
Manufacturer Narrative
Patient code 3191 captures the reportable event of surgery.This correction report is being sent to include the explant date.
 
Event Description
It was reported that this patient experienced ventricular fibrillation (vf) which was treated appropriately with a shock and was successfully converted back to a normal rhythm.However, shortly after this vf episode, the patient experienced ventricular tachycardia (vt) and was appropriately treated with seven shocks to end the vt episode.Device interrogation revealed a code 1005, indicating an open circuit condition.Boston scientific technical services was contacted and it was noted that during the shock deliveries, there were multiple high, out of range (>125 ohms) shock impedance measurements from this right ventricular (rv) lead.Rv lead replacement was recommended to resolve the event.The physician elected to surgically explant and replace this rv lead.During the procedure, damage was seen to the device setscrew and the physician elected to also explant and replace the device to resolve the event.The patient was stable with no additional adverse consequences.The associated icd was returned for laboratory analysis.It was reported that the referenced rv lead was destroyed during the extraction process and was discarded at the hospital.
 
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Brand Name
ENDOTAK RELIANCE
Type of Device
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
4100 hamline avenue north
saint paul MN 55112
MDR Report Key11128110
MDR Text Key225488324
Report Number2124215-2020-27623
Device Sequence Number1
Product Code LWS
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 07/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/06/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date03/31/2006
Device Model Number0161
Device Catalogue Number0161
Was Device Available for Evaluation? No
Date Manufacturer Received05/17/2021
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age29 YR
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