MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION THE Q-TRAK SUBCUTANEOUS ELECTRODE; IMPLANTABLE LEAD

Model Number 3010

Device Problems High impedance (1291); Failure to Sense (1559); Defibrillation/Stimulation Problem (1573); Under-Sensing (1661); Low impedance (2285); Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/14/2021

Event Type  Injury  

Manufacturer Narrative

The product has been received for analysis.This report will be updated upon completion of analysis.

Event Description

It was reported that the patient underwent a replacement procedure for normal battery depletion.Prior to the procedure a 10 joule shock was delivered and yielded an impedance measurement of 120 ohms.It was noted that an x-ray had been taken a year earlier and indicated there was not a good electrode position.It was planned to first remove the capsule in the device pocket in order to lower the shock impedance.After the bag was closed and connected to the new device, another 10 joule synchronized shock with an impedance of 116 ohms occurred.They put the patient into ventricular fibrillation (vf) as desired by the physician, and the newly implanted s-icd detected the arrhythmia.Time to therapy was under 20 seconds.After the shock is delivered, a zero line appeared for about 10 seconds, but the patient still was in vf.The vf signals reappeared after approximately 10 more seconds, but the s-icd no longer detected every complex and no longer recognized a tachycardia arrhythmia.The shock impedance measurement was now at 3 ohms.External defibrillation was successful.Subsequently the new s-icd was attempted and not implanted.A new s-icd and electrode were implanted with no further issues and a shock impedance measurement of 72 ohms.No additional adverse patient effects were reported.

Manufacturer Narrative

The product has been received for analysis.This report will be updated upon completion of analysis.Upon receipt at our post market quality assurance laboratory, visual inspection revealed and coil deformation due to insulation abrasion.Resistance testing determined that the distal high voltage cable was fractured approximately 11.5 cm from the terminal pin.This type of damage is consistent with repeated stress over time.In this case, we believe the stress was the result of lead contact with another lead.The reported low out of range and high shock impedance measurements are likely the result of the lead damage observed by the laboratory.

Event Description

It was reported that the patient underwent a replacement procedure for normal battery depletion.Prior to the procedure a 10 joule shock was delivered and yielded an impedance measurement of 120 ohms.It was noted that an x-ray had been taken a year earlier and indicated there was not a good electrode position.It was planned to first remove the capsule in the device pocket in order to lower the shock impedance.After the bag was closed and connected to the new device, another 10 joule synchronized shock with an impedance of 116 ohms occurred.They put the patient into ventricular fibrillation (vf) as desired by the physician, and the newly implanted s-icd detected the arrhythmia.Time to therapy was under 20 seconds.After the shock is delivered, a zero line appeared for about 10 seconds, but the patient still was in vf.The vf signals reappeared after approximately 10 more seconds, but the s-icd no longer detected every complex and no longer recognized a tachycardia arrhythmia.The shock impedance measurement was now at 3 ohms.External defibrillation was successful.Subsequently the new s-icd was attempted and not implanted.A new s-icd and electrode were implanted with no further issues and a shock impedance measurement of 72 ohms.No additional adverse patient effects were reported.

Event Description

It was reported that the patient underwent a replacement procedure for normal battery depletion.Prior to the procedure a 10 joule shock was delivered and yielded an impedance measurement of 120 ohms.It was noted that an x-ray had been taken a year earlier and indicated there was not a good electrode position.It was planned to first remove the capsule in the device pocket in order to lower the shock impedance.After the bag was closed and connected to the new device, another 10 joule synchronized shock with an impedance of 116 ohms occurred.They put the patient into ventricular fibrillation (vf) as desired by the physician, and the newly implanted s-icd detected the arrhythmia.Time to therapy was under 20 seconds.After the shock is delivered, a zero line appeared for about 10 seconds, but the patient still was in vf.The vf signals reappeared after approximately 10 more seconds, but the s-icd no longer detected every complex and no longer recognized a tachycardia arrhythmia.The shock impedance measurement was now at 3 ohms.External defibrillation was successful.Subsequently the new s-icd was attempted and not implanted.A new s-icd and electrode were implanted with no further issues and a shock impedance measurement of 72 ohms.No additional adverse patient effects were reported.

Manufacturer Narrative

The product has been received for analysis.This report will be updated upon completion of analysis.Upon receipt at our post market quality assurance laboratory, visual inspection revealed and coil deformation due to insulation abrasion.Resistance testing determined that the distal high voltage cable was fractured approximately 11.5 cm from the terminal pin.This type of damage is consistent with repeated stress over time.In this case, we believe the stress was the result of lead contact with the device.The reported low out of range and high shock impedance measurements are likely the result of the lead damage observed by the laboratory.This report was filed to correct the text in the additional manufacturer narrative.There was an inadvertent typo that indicated lead on lead contact, however it should read lead on device contact.The text was updated.

Manufacturer Narrative

The product has been received for analysis.This report will be updated upon completion of analysis.Upon receipt at our post market quality assurance laboratory, visual inspection revealed and coil deformation due to insulation abrasion.Resistance testing determined that the distal high voltage cable was fractured approximately 11.5 cm from the terminal pin.This type of damage is consistent with repeated stress over time.In this case, we believe the stress was the result of lead contact with the device.The reported low out of range and high shock impedance measurements are likely the result of the lead damage observed by the laboratory.Upon receipt at our post market quality assurance laboratory, visual inspection noted insulation abrasion through to the conductor at 11.5 cm from the terminal pin.Resistance testing determined that the conductor measurement was discontinuous at the same location, which indicated there was no therapy available to the patient.The conductor coil was melted indicating the electrical conduction arced to the can of the s-icd.The appearance of the abrasion and conductor damage is consistent with repetitive lead contact with the s-icd over time.The reported abnormal defibrillation impedance measurements and oversensing are likely the result of the lead damage observed by the laboratory.This report was filed to correct the text in the additional manufacturer narrative.There was an inadvertent typo that indicated lead on lead contact, however it should read lead on device contact.The text was updated.

Event Description

It was reported that the patient underwent a replacement procedure for normal battery depletion.Prior to the procedure a 10 joule shock was delivered and yielded an impedance measurement of 120 ohms.It was noted that an x-ray had been taken a year earlier and indicated there was not a good electrode position.It was planned to first remove the capsule in the device pocket in order to lower the shock impedance.After the bag was closed and connected to the new device, another 10 joule synchronized shock with an impedance of 116 ohms occurred.They put the patient into ventricular fibrillation (vf) as desired by the physician, and the newly implanted s-icd detected the arrhythmia.Time to therapy was under 20 seconds.After the shock is delivered, a zero line appeared for about 10 seconds, but the patient still was in vf.The vf signals reappeared after approximately 10 more seconds, but the s-icd no longer detected every complex and no longer recognized a tachycardia arrhythmia.The shock impedance measurement was now at 3 ohms.External defibrillation was successful.Subsequently the new s-icd was attempted and not implanted.A new s-icd and electrode were implanted with no further issues and a shock impedance measurement of 72 ohms.No additional adverse patient effects were reported.

• Brand Name: THE Q-TRAK SUBCUTANEOUS ELECTRODE
• Type of Device: IMPLANTABLE LEAD
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 229 avenida fabricante; san clemente CA 92672
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 13328859
• MDR Text Key: 284287738
• Report Number: 2124215-2021-39945
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P110042/S000
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/08/2022

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 Date: 09/01/2015
• Device Model Number: 3010
• Device Catalogue Number: 3010
• Device Lot Number: A109023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/14/2021
• Initial Date FDA Received: 01/22/2022
• Supplement Dates Manufacturer Received: 08/09/2022; 09/08/2022; 09/08/2022
• Supplement Dates FDA Received: 09/06/2022; 09/08/2022; 09/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization