MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ALTRUA 20; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

Model Number	S208
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Codes	No Code Available (3191); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.(b)(4).
Event or Problem Description
It was reported that this pacemaker previously displayed two years remaining with increased right ventricular (rv) outputs then reached elective replacement time (ert) after a month.Boston scientific technical services (ts) explained that longevity calculation is not possible with old device and recommended device replacement for evaluation.Subsequently, this device was explanted.No additional 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 eol.The device functioned normally throughout testing.Laboratory analysis determined that this device experienced normal battery depletion; however, it was reported from the field that 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 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.Of note, the estimated remaining battery longevity of this pacemaker was designed to be calculated and trigger corresponding device replacement indicators based on the pacing capacitor charge time, which progressively increases as the battery depletes.These pacemakers were not designed with an ability to calculate remaining longevity for every possible current drain, which may cause replacement indicators to trigger earlier than what was previously estimated; however, it does not negatively impact the use, operation, safety, or performance of the device.If information is provided in the future, a supplemental report will be issued.Patient code 3191 captures the reportable event of surgery.
Event or Problem Description
It was reported that this pacemaker previously displayed two years remaining with increased right ventricular (rv) outputs then reached elective replacement time (ert) after a month.Boston scientific technical services (ts) explained that longevity calculation is not possible with old device and recommended device replacement for evaluation.Subsequently, this device was explanted.No additional adverse patient effects were reported.

• Brand Name: ALTRUA 20
• Common Device Name: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 10756488
• Report Number: 2124215-2020-22520
• Device Sequence Number: 14282283
• Product Code: LWP
• UDI-Device Identifier: 00802526484421
• UDI-Public: 00802526484421
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: N970003/S106
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2021

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: 05/14/2012
• Device Model Number: S208
• Device Catalogue Number: S208
• Device Lot Number: 594257
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2020
• Initial Date Received by Manufacturer: 07/02/2020
• Supplement Date Received by Manufacturer: 01/11/2021
• Initial Report FDA Received Date: 10/29/2020
• Supplement Report FDA Received Date: 05/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention