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

Device Problem Microbial Contamination of Device (2303)

Patient Problems Abscess (1690); Bacterial Infection (1735); No Code Available (3191)

Event Date 06/15/2019

Event Type  Injury  

Event Description

Obtained from consult note from (b)(6) 2019 for pacemaker removal: (b)(6) female who has pacer placed (b)(6) 2019 (pacemaker insertion - boston scientific (b)(6) 2019) for episodic bradycardia, she developed what sounds like a stitch abscess and per ep report there was pseudomonas, she has been on iv antibiotics and was hospitalized for a week, she is on her 2nd week of iv antibiotics via picc line.Pacemaker to left side of chest became infected in (b)(6) 2019.She was treated with oral antibiotic.Once treatment was completed she was hospitalized at (b)(6).Pacemaker was subsequently removed due to infection in (b)(6) 2019.Admit: (b)(6) 2019 (est.Based on available information); disch: unknown.

• 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: 10355627
• MDR Text Key: 201534247
• Report Number: MW5095832
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 71 YR
• Patient Weight: 84