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

Model Number	V272
Medical Device Problem Codes	High impedance (1291); Ambient Noise Problem (2877)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/28/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time, the device remains in service.If additional information is received, this report will be updated.
Event or Problem Description
Boston scientific received information that this cardiac resynchronization therapy pacemaker (crt-p) exhibited high right ventricular (rv) pacing impedance measurements of greater than 2000 ohms and noise.A surgical revision was performed.The patient's rv lead was not tested via the pacing system analyzer (psa).The rv lead was surgically abandoned and replaced, and when the new lead was connected to this device, all measurements were within normal limits.No additional adverse patient effects were reported.The device remains in service.

• Brand Name: INGENIO
• Common Device Name: IMPLANTABLE PULSE GENERATOR
• Manufacturer (Section D): GUIDANT CRM CLONMEL IRELAND; guidant ireland; clonmel, tipperary ireland
• MDR Report Key: 6717934
• Report Number: 2124215-2017-12372
• Device Sequence Number: 1735355
• Product Code: NKE
• UDI-Device Identifier: 00802526536663
• UDI-Public: (01)00802526536663(17)20160610
• Combination Product (Y/N): N
• PMA/510(K) Number: P030005/S092
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/28/2017

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: 06/10/2016
• 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: 06/28/2017
• Initial Report FDA Received Date: 07/17/2017
• 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: 4088; 4518; H125; V272
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 74 YR