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

Model Number E110

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Pain (1994)

Event Date 11/15/2018

Event Type  Injury  

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, the allegation against the device was not confirmed.The setscrew moved freely, and the ports were tested and passed.The device was put through and passed the returned products test.

Event Description

It was reported that patient with this implantable cardioverter defibrillator (icd) device underwent a 2.5 hours dialysis and then felt pain around his device.The patient stated that the pain went away when the dialysis stopped.Boston scientific technical services (ts) referred the patient to contact the physician.Furthermore, the device was explanted.No additional adverse patient effects were reported.

• Type of Device: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 9270310
• MDR Text Key: 164805679
• Report Number: 2124215-2019-23237
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960040/S155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/19/2011
• Device Model Number: E110
• Device Catalogue Number: E110
• Device Lot Number: 139032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2019
• Initial Date Manufacturer Received: 07/31/2019
• Initial Date FDA Received: 11/02/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 85 YR