MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ALTRUA 2 DR; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

Model Number	S702
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/26/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Upon receipt at our post market quality assurance laboratory, this device was thoroughly inspected and analyzed.Visual examination identified no device irregularities.A longevity calculation was completed and confirmed this device did not last as long as expected.Additionally, a high current drain was detected.The device case was opened to facilitate analysis of the internal components.Detailed analysis confirmed the identified high current drain was a result of two leaky capacitors.Investigation determined that the premature battery depletion was caused by the presence of excess hydrogen in the device case, and the source of the hydrogen was a liner component within the device.This device is not part of the hydrogen induced premature depletion advisory population.
Event or Problem Description
It was reported that this pacemaker battery appeared to be prematurely depleting based on previous battery longevity checks.Subsequently, surgical intervention was performed to explant and replace device.No adverse patient effects were reported.

• Brand Name: ALTRUA 2 DR
• 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: 10606383
• Report Number: 2124215-2020-19319
• Device Sequence Number: 2410074
• Product Code: LWP
• UDI-Device Identifier: 00802526559341
• UDI-Public: 00802526559341
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: N970003/S167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/30/2020

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: 07/21/2017
• Device Model Number: S702
• Device Catalogue Number: S702
• Device Lot Number: 700206
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/02/2020
• Initial Report FDA Received Date: 09/30/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention