MAUDE Adverse Event Report: BOSTON SCEINTIFIC CORPORATION BOSTON SCIENTIFIC ENERGEN ICD E142; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

Model Number E142

Device Problem Power Problem (3010)

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

Event Date 02/09/2022

Event Type  malfunction  

Event Description

Error code 1003.Voltage is too low for projected remaining capacity.Boston scientific recommended 90 day possible change out.Fda safety report id #:(b)(4).

• Brand Name: BOSTON SCIENTIFIC ENERGEN ICD E142
• Type of Device: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
• Manufacturer (Section D): BOSTON SCEINTIFIC CORPORATION
• MDR Report Key: 13548893
• MDR Text Key: 285815554
• Report Number: MW5107515
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: E142
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 48 YR
• Patient Sex: Male
• Patient Weight: 136 KG
• Patient Ethnicity: Hispanic
• Patient Race: Black Or African American