MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ACCOLADE MRI EL DR; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

Model Number L331

Device Problems Contamination (1120); Contamination /Decontamination Problem (2895)

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

Event Date 02/22/2022

Event Type  Injury  

Manufacturer Narrative

The device will be returned for analysis.Upon return and analysis completion this investigation will be updated.

Event Description

It was reported that during a follow up high pace impedance measurements were exhibited on this right ventricular (rv) lead as well loss of capture.A revision took place as a result and a lead fracture was seen, thus this lead was explanted and will be returned.When placing a new electrode with this device evidence of a corroded and oxidized zone in the area of the header was seen, thus the device was also replaced and will be returned.No adverse patient effects were reported.

Event Description

It was reported that during a follow up high pace impedance measurements were exhibited on this right ventricular (rv) lead as well loss of capture.A revision took place as a result and a lead fracture was seen, thus this lead was explanted and will be returned.When placing a new electrode with this device evidence of a corroded and oxidized zone in the area of the header was seen, thus the device was also replaced and will be returned.No adverse patient effects were reported.

Manufacturer Narrative

The device was expected to be returned for analysis.Upon return and analysis completion this investigation will be updated.

Event Description

It was reported that during a follow up high pace impedance measurements were exhibited on this right ventricular (rv) lead as well loss of capture.A revision took place as a result and a lead fracture was seen, thus this lead was explanted and will be returned.When placing a new electrode with this device evidence of a corroded and oxidized zone in the area of the header was seen, thus the device was also replaced and will be returned.No adverse patient effects were reported.Additional information noted that there was no issue with device l331/923437 and the device remains implanted.Additional information regarding device l331/924236 can be reviewed in report 14937485.

• Brand Name: ACCOLADE MRI EL DR
• Type of Device: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
• 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: 14176330
• MDR Text Key: 289812560
• Report Number: 2124215-2022-07573
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Reporter Country Code: BL
• PMA/PMN Number: P150012/S000
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/23/2023
• Device Model Number: L331
• Device Catalogue Number: L331
• Device Lot Number: 924236
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 67 YR
• Patient Sex: Female