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

Model Number	S203
Medical Device Problem Codes	Premature Discharge of Battery (1057); Capturing Problem (2891)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/08/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
At this time, the product has not been returned.If the product is returned, analysis will be performed and this report would be updated at that time.
Event or Problem Description
Additional information was received indicating that the device was explanted.
Additional Manufacturer Narrative
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 pacemaker had reached elective replacement indicator (eri).A month before the pacemaker reached eri, the battery status showed two years remaining and the right ventricular (rv) output was at 6.5 volts.Boston scientific technical services (ts) explained this could be normal battery depletion (nbd) due to the increased in rv output.Ts advised to have device data analysis however, the health care professional (hcp) declined.Additional information was received indicating that eri was confirmed and that the patient was scheduled for device changeout.To date pacemaker still remains in service.No adverse patient effects were reported.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, detailed mechanical and electrical testing was performed on the device.The device battery status was elective replacement time (ert).The device functioned normally throughout testing.Laboratory analysis determined that this device experienced normal battery depletion; however, the estimated longevity remaining value appeared to decrease more quickly than expected between routine follow-ups.Factors influencing the estimated longevity remaining calculation include pacing rate, amplitude, pulse-width and lead impedance.Any even slight changes in these factors will impact the battery consumption calculation and therefore the remaining longevity estimate.Please note that, despite the drop in estimated longevity remaining, the actual battery condition did not change significantly between follow-ups.In summary, it was determined that this device experienced normal battery depletion, but declared ert earlier than previously estimated.

• Brand Name: ALTRUA
• Common Device Name: IMPLANTABLE PULSE GENERATOR
• Manufacturer (Section D): GUIDANT CRM CLONMEL IRELAND; guidant ireland; clonmel, tipperary ireland
• MDR Report Key: 6296674
• Report Number: 2124215-2016-18678
• Device Sequence Number: 11039252
• Product Code: LWP
• UDI-Device Identifier: 00802526484391
• UDI-Public: (01)00802526484391(17)20130126
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/23/2017

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: 01/26/2013
• Device Model Number: S203
• Other Device ID Number: ALTRUA 20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2016
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/29/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 02/02/2017
• Supplement Report FDA Received Date: 02/02/2017; 04/27/2017
• 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: (B)(4); (B)(4); (B)(4); (B)(4); (B)(4)
• Patient Age: 85 YR