MAUDE Adverse Event Report: NEURX DIAPHRAGM PACING SYSTEM; DIA[PHRAGM PACING SYSTEM

Model Number	23-0021
Medical Device Problem Code	Electrical Overstress (2924)
Health Effect - Clinical Code	Undesired Nerve Stimulation (1980)
Date of Event	04/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to directions provided to clinicians in the instructions for use, all patients are to be tested for cardiac interactions with the device at maximum stimulation settings at the time of electrode implantation.In the reported event, a component (resistor) failure on an internal pcb of the external pulse generator (epg) caused the device amplitude output to exceed the software controlled upper amplitude limit.This created a situation where the patient was subjected to stimulation beyond the limit that had been tested for cardiac interaction.When tested during surgery at maximum settings the patient will receive a charge of 5.0uc.The component failure created a change density of 5.4uc, or 8% over the tested output.No cardiac interaction was observed during the event but the patient was exposed to conditions beyond those previously tested when the device was implanted.The resistor failure appears to have been caused by damage on the pcb of the external pulse generator during the manufacturing process.The damaged resistor went undetected by the post-pcb assembly automated optical inspection of the subcontractor, the pcb incoming visual inspection at the manufacturer and the pre and post burn-in functional testing performed prior to final release.It is believed the resistor was damaged in-process but did not fail until after distribution.The device failed at initial use as described.
Event or Problem Description
The patient's older external pulse generator (epg, approx 8 years old) was being exchanged for a new epg.The stimulation settings were retrieved from the old epg and were programmed into the new epg.When stimulation was started with the new epg the patient experienced intense pain and stimulation was discontinued.The settings were verified but the patient again experienced intense pain when stimulation was initiated a second time.The old epg was left with the patient and the new device was returned to the manufacturer for evaluation.

• Brand Name: NEURX DIAPHRAGM PACING SYSTEM
• Common Device Name: DIA[PHRAGM PACING SYSTEM
• MDR Report Key: 11872593
• Report Number: 3005868392-2021-00001
• Device Sequence Number: 1152772
• Product Code: OIR
• UDI-Device Identifier: 00852184003212
• UDI-Public: 852184003212
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: H070003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 05/24/2021

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: Other
• Device Model Number: 23-0021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2021
• Initial Report FDA Received Date: 05/24/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/02/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other