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

Model Number	S203
Medical Device Problem Codes	Impedance Problem (2950); Protective Measures Problem (3015)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/27/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This investigation will be updated should further information be provided.
Event or Problem Description
Boston scientific received information that the battery indicator of this pacemaker displayed an estimated longevity of 1.5 years with a magnet rate of 90 pacing pulses per minute during a scheduled follow-up.It then dropped to less than 6 months after completing the follow-up even though no programming changes were made.Boston scientific technical services (ts) discussed how the device calculates the longevity and the gas gauge presentation.Ts also suggested to have the disk analyzed.Data analysis later showed that a small decrease in the ventricular impedance caused the bin to switch thus causing the longevity estimate to drop to less than 6 months.No inappropriate battery depletion was noted.Ts advised to have the device closely monitored.No adverse patient effects were reported.The device remains in service.

• Brand Name: ALTRUA
• Common Device Name: IMPLANTABLE PULSE GENERATOR
• Manufacturer (Section D): GUIDANT CRM CLONMEL IRELAND; guidant ireland; clonmel, tipperary ireland
• MDR Report Key: 5794332
• Report Number: 2124215-2016-10911
• Device Sequence Number: 16302181
• Product Code: LWP
• UDI-Device Identifier: 00802526484391
• UDI-Public: (01)00802526484391(17)20130711
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 05/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 07/11/2013
• Device Model Number: S203
• Other Device ID Number: ALTRUA 20
• 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: 05/27/2016
• Initial Report FDA Received Date: 07/14/2016
• 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
• Patient Age: 74 YR