Model Number 37800 |
Device Problems
Premature Discharge of Battery (1057); Failure to Deliver Energy (1211); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)
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Patient Problems
Nausea (1970); Therapeutic Effects, Unexpected (2099); Vomiting (2144); Complaint, Ill-Defined (2331); Malaise (2359)
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Event Date 01/01/2018 |
Event Type
Injury
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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Information was received from a healthcare professional (hcp) regarding a patient with an implantable neurostimulator (ins) for gastric stimulation.It was reported that the hcp saw a por with a code of 0x0 on the clinician programmer screen.The hcp moved forward through the screens and updated the date and time and interrogated the ins again and it then came up with eos (end of service).It was noted that there was an allegation/dissatisfaction with the ins longevity as the ins was just replaced in (b)(6) 2017.There were no traumas/falls that could be related to the issue.The patient had symptoms in the abdomen, felt that stimulation was turned off for the past 2 weeks, and they had not been feel well for (b)(6) 2018.No further complications were reported/anticipated.
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Manufacturer Narrative
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Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Additional information received from the healthcare provider (hcp) indicated that they noticed an increase in nausea/vomiting, and the patient couldn't "feel" the stimulator anymore.They checked the battery status, and it was dead after one year.There were no further complications reported as a result of this event.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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Additional information was received from a healthcare professional (hcp).It was reported that the patient¿s device was replaced on (b)(6) 16 and not (b)(6) 2017.The patient called when they felt it had been long enough and it needed to be interrogated; the battery was checked on (b)(4) and scheduled for a battery change on (b)(4).It was noted that the readings were retook multiple times.It was noted that the cause of the por and eos messages was that the battery was dead or no longer functioning.No further complications were reported/anticipated.
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Manufacturer Narrative
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Analysis of the ins (b)(4) revealed that the output and telemetry were acceptable; however, the battery is near normal battery depletion.There was good, stable output on the electrode pairs the ins had when it was received and good, stable output on all pairs.There were no issues when pressing on the ins can.A computer longevity estimate was completed based on the parameters the device had when it was received for analysis.The information obtained indicated that the device had reached eos (end of service).If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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