MAUDE Adverse Event Report: IMPULSE DYNAMICS (USA) INC. OPTIMIZER SMART SYSTEM; IMPLANTABLE PULSE GENERATOR

Model Number	10-A604-3-US
Medical Device Problem Code	Data Problem (3196)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The discrepancy between the programmer screen display and the hard copy print-out of the zebra printer was first observed at (b)(6).The programmer was not returned to manufacturer.Replicates of the exact same programmer and zebra printer were taken from stock inventory in the us and (b)(6) and the discrepancy was reproducible.The contract manufacturer for the programmer was contacted and initial evaluation is that there is a software bug that requires some text labels to be corrected in the existing software code.The fix is being developed and will be implemented in the field.
Event or Problem Description
The omni ii programmer with omni smart application software is used to program the optimizer smart ipg.Omni ii programmer with omni smart application software screen display does not match hard copy paper print-out from associated zebra printer.The values for %therapy total and %therapy 24 hours are transposed.The values on programmer display screen are correct.The physician users rarely use the zebra printer hard copy but the possibility exists that in some rare case the physician may decide to use it or place it in the patient medical record.Because the physician will adjust therapy on the basis of the programmer screen display, the risk of harm to the patient is remote.
Additional Manufacturer Narrative
The discrepancy between the programmer screen display and the hard copy print-out of the zebra printer was first observed at the university of mannheim in germany.The programmer was not returned to manufacturer.Replicates of the exact same programmer and zebra printer were taken from stock inventory in the us and germany and the discrepancy was reproducible.The contract manufacturer for the programmer was contacted and initial evaluation is that there is a software bug that requires some text labels to be corrected in the existing software code.The fix is being developed and will be implemented in the field.H11 - corrected data ((b)(6) 2020) the device malfunction reported was a software bug where the values for %therapy were incorrect for the hard copy printer output but correct on the display screen of the programmer.There was no serious injury, harm or death to the patient.After reviewing the risks, it is unlikely the recurrence of this discrepancy would lead to patient harm because most sites do not use the zebra printer involved and the values transposed are relatively close in clinical application.Impulse dynamics is reporting this event out of caution.A fsca was conducted whereby a resolution to the software bug was loaded onto affected programmers as an upgrade to the units.The fsca has been mostly completed with a very small number of units that have not been upgraded yet due to limited access posed by the covid-19 crisis.These will be completed as soon as access is granted.The upgrades have been successful and the upgrade introduces no new risks.There is a low chance that the software bug will recur with upgraded programmers.This matter is deemed to be closed from the manufacturer's perspective.
Event or Problem Description
Omni ii programmer with omni smart application software screen display does not match hard copy paper print-out from associated zebra printer.The values for %therapy total and %therapy 24 hours are transposed.The values on programmer display screen are correct.The physician users rarely use the zebra printer hard copy but the possibility exists that in some rare case the physician may decide to use it or place it in the patient medical record.Because the physician will adjust therapy on the basis of the programmer screen display, the risk of harm to the patient is remote.Patient problem code : 2199 (no consequences or impact to patient).

• Brand Name: OPTIMIZER SMART SYSTEM
• Common Device Name: IMPLANTABLE PULSE GENERATOR
• Manufacturer (Section D): IMPULSE DYNAMICS (USA) INC.; 1 blue hill plaza, floor 16; suite 11610; pearl river NY 10965
• MDR Report Key: 10323349
• Report Number: 3007805252-2020-00001
• Device Sequence Number: 19682835
• Product Code: QFV
• UDI-Device Identifier: 00810003380012
• UDI-Public: 00810003380012
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P180036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2020

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: Health Professional
• Device Model Number: 10-A604-3-US
• Device Catalogue Number: 10-A604-3-US
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/24/2020
• Supplement Report FDA Received Date: 02/04/2021
• 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: N/A.
• Outcome Attributed to Adverse Event: Other