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

Model Number	S722
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Following return and completion of laboratory analysis, this event will be further updated.
Event or Problem Description
It was reported that during a post implant interrogation, three device resets were exhibited and the device consequently in safety mode.Technical services (ts) was called to provide guidance regarding the operation of this unexpected programing operation.Ts stated that once in safety mode, the device would need to be explanted and replaced.No additional adverse events were reported and replacement later that same day was confirmed.The explanted device will be returned for analysis.Another device of same model type was implanted without further complications.
Event or Problem Description
It was reported that during a post implant interrogation, three device resets were exhibited and the device consequently in safety mode.Technical services (ts) was called to provide guidance regarding the operation of this unexpected programing operation.Ts stated that once in safety mode, the device would need to be explanted and replaced.No additional adverse events were reported and replacement later that same day was confirmed.The explanted device was returned for analysis.Another device of same model type was implanted without further complications.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, this device was thoroughly inspected and analyzed.Interrogation of the device confirmed it was operating in safety mode and that brady therapy remained available.Review of device memory identified an error.The error resulted in software resets performed in an attempt to correct an identified memory inconsistency.The corrupted memory was corrected in the laboratory and the device reverted to normal operation.The cause of the memory inconsistency was not able to be determined through laboratory testing but was likely the result of exposure to radiation, either therapeutic or environmental.

• Brand Name: ALTRUA 2 EL 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: 11668826
• Report Number: 2124215-2021-07866
• Device Sequence Number: 14302132
• Product Code: LWP
• UDI-Device Identifier: 00802526559365
• UDI-Public: 00802526559365
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: N970003/S167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2021

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: Health Professional
• Device Expiration Date: 05/15/2022
• Device Model Number: S722
• Device Catalogue Number: S722
• Device Lot Number: 704636
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2021
• Initial Date Received by Manufacturer: 03/08/2021
• Supplement Date Received by Manufacturer: 08/20/2021
• Initial Report FDA Received Date: 04/14/2021
• Supplement Report FDA Received Date: 10/10/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention