MAUDE Adverse Event Report: GUIDANT CRM CLONMEL IRELAND INGENIO; IMPLANTABLE PULSE GENERATOR

Model Number	V272
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Complaint, Ill-Defined (2331)
Date of Event	01/11/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device remains implanted.As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.
Event or Problem Description
Boston scientific received information that this patient complained of a pulling sensation when he moved his shoulder.Additional information stated the physician suspected the cardiac resynchronization therapy pacemaker (crt-p) was sutured in an inadequate position.The physician later determined the crt-p had migrated from its original position.The patient underwent a pocket revision, in which the crt-p was repositioned.The crt-p remains in service.No adverse patient effects were reported.

• Brand Name: INGENIO
• Common Device Name: IMPLANTABLE PULSE GENERATOR
• Manufacturer (Section D): GUIDANT CRM CLONMEL IRELAND; guidant ireland; clonmel, tipperary ireland
• MDR Report Key: 7350464
• Report Number: 2124215-2018-01451
• Device Sequence Number: 13649361
• Product Code: NKE
• UDI-Device Identifier: 00802526536663
• UDI-Public: 00802526536663
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/11/2018

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/16/2017
• Device Model Number: V272
• Other Device ID Number: INTUA
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2018
• Initial Report FDA Received Date: 03/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 4470; 4471; 4518; H125; V272
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 82 YR