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 Consequences Or Impact To Patient (2199)
Date of Event	01/18/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time, the product has not been returned.If the product is returned, analysis will be performed and this report updated at that time.
Event or Problem Description
It was reported that this pacemaker was suspected of exhibiting premature battery depletion.After 3 years of implant the estimated remaining longevity was found at approximately 7 months.Boston scientific technical services (ts) reviewed device data noting power consumption had been increasing over the previous year; device replacement was recommended.A revision procedure was later performed wherein this device was explanted; no further details could be obtained.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: 8509305
• Report Number: 2124215-2019-06083
• Device Sequence Number: 1955728
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/12/2019

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: 07/20/2017
• Device Model Number: S702
• Device Catalogue Number: S702
• Device Lot Number: 700246
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2019
• Initial Report FDA Received Date: 04/12/2019
• 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; Life Threatening; Required Intervention