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

Model Number L331

Device Problems Crack (1135); Pacing Intermittently (1443); Device Sensing Problem (2917); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Syncope/Fainting (4411)

Event Date 03/04/2021

Event Type  malfunction  

Event Description

Patient admitted 3 days after pacemaker generator change with syncope.Tele in er showed intermittent inhibition of pacing with prolonged pauses.The new pacer had malfunctioned and switched to "safety core" mode.The included vvi mode with sensitivity 0.25 mv unipolar which resulted in far field and/or myopotential sensing and inhibited ventricular output.A temporary place was placed.The permanent pacemaker generator was replaced.The ventricular lead was found to have an insulated crack at the pin insertion point though electrical measurements were normal.New right ventricular pacing lead was implanted along with a new generator.Manufacturer response for accolade mri (b)(4), (brand not provided) (per site reporter) the product was given to boston scientific for evaluation.

• Brand Name: ACCOLADE
• Type of Device: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11648168
• MDR Text Key: 244894810
• Report Number: 11648168
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: L331
• Device Catalogue Number: L331
• Device Lot Number: 916474
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/19/2021
• Event Location: Hospital
• Date Report to Manufacturer: 04/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 29565 DA