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

Model Number 4549_0185 4136

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Skin Erosion (2075)

Event Type  Injury  

Event Description

Pt device eroded through skin so physician extracted system (b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
• Type of Device: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 17536250
• MDR Text Key: 321047749
• Report Number: MW5143140
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: 4549_0185 4136
• Patient Sequence Number: 1