MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INOGEN EL ICD VR; IMPLANTABLE DEVICE

Model Number D140

Device Problems Signal Artifact/Noise (1036); Failure to Capture (1081); Failure to Sense (1559); Low impedance (2285); Impedance Problem (2950); Data Problem (3196); Migration (4003)

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

Event Date 11/30/2020

Event Type  Injury  

Manufacturer Narrative

Information indicates this device is currently in the possession of a boston scientific representative and will be returned.This investigation will be updated should further information be provided.

Event Description

It was reported that this single chamber implantable cardioverter defibrillator (icd) system exhibited a change in the sensing morphology on stored electrograms where it appeared that the patient no longer had an intrinsic rhythm.Attempts were made over several months to have the patient come into the clinic for an evaluation, testing and possible device programming optimization.However, the patient did not come to scheduled follow up appointments.Subsequently, there were additional observations of no sensing, no capture and poor impedance measurements on the right ventricular (rv) lead.There were also stored episodes which exhibited various types of noise and the shock impedance measurements were less than 10 ohms since approximately one month after system implant.These shock impedance measurements are low and out of range.The patient is very large and soon after system implant when the patient sat up, it appeared that the icd device had migrated.With the patient subsequently in the clinic, a new x-ray was performed.The device and rv lead were found to have migrated and the rv lead was dislodged.Due to the patients non-compliance with attending scheduled follow up appointments, the physician elected to explant the icd device and rv lead and not replace the system.There were no additional adverse patient effects.

Manufacturer Narrative

Information indicates this device is currently in the possession of a boston scientific representative and will be returned.This investigation will be updated should further information be provided.The returned device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.Visual examination of the device header and case noted scratches and tool marks on the case.The device was then exposed to simulated heart load conditions, and the defibrillation, pacing, and sensing functions were tested.Impedance testing was completed, and all measurements were within normal limits.The device operated appropriately with no interruptions in therapy output at the returned programmed settings.A series of electrical tests was also performed, and again, normal device function was observed.Device migration is a known issue for implanted devices.Analysis of the returned product is not able to provide relevant information pertinent to this type of allegation.

Event Description

It was reported that this single chamber implantable cardioverter defibrillator (icd) system exhibited a change in the sensing morphology on stored electrograms where it appeared that the patient no longer had an intrinsic rhythm.Attempts were made over several months to have the patient come into the clinic for an evaluation, testing and possible device programming optimization.However, the patient did not come to scheduled follow up appointments.Subsequently, there were additional observations of no sensing, no capture and poor impedance measurements on the right ventricular (rv) lead.There were also stored episodes which exhibited various types of noise and the shock impedance measurements were less than 10 ohms since approximately one month after system implant.These shock impedance measurements are low and out of range.The patient is very large and soon after system implant when the patient sat up, it appeared that the icd device had migrated.With the patient subsequently in the clinic, a new x-ray was performed.The device and rv lead were found to have migrated and the rv lead was dislodged.Due to the patients non-compliance with attending scheduled follow up appointments, the physician elected to explant the icd device and rv lead and not replace the system.There were no additional adverse patient effects.

• Brand Name: INOGEN EL ICD VR
• Type of Device: IMPLANTABLE DEVICE
• 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 Key: 12218327
• MDR Text Key: 263171030
• Report Number: 2124215-2021-20634
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526534201
• UDI-Public: 00802526534201
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960040/S306
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 05/26/2022

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: 02/04/2022
• Device Model Number: D140
• Device Catalogue Number: D140
• Device Lot Number: 265983
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/01/2021
• Initial Date FDA Received: 07/23/2021
• Supplement Dates Manufacturer Received: 05/17/2022
• Supplement Dates FDA Received: 05/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/13/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 37 YR
• Patient Sex: Male