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

Model Number S205

Device Problems Battery Problem (2885); Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Date 08/23/2021

Event Type  malfunction  

Event Description

Per call with hcp (b)(6) from the office of or (b)(6) stated that this pt had a battery depletion.And the only info she had is the bsx device removed and replaced by mdt on (b)(6) 2021.(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
• MDR Report Key: 17527406
• MDR Text Key: 321405255
• Report Number: MW5134338
• 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: 10/18/2021

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: S205
• Patient Sequence Number: 1