Model Number 97702 |
Device Problems
Low Battery (2584); Device Displays Incorrect Message (2591); Battery Problem (2885)
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Patient Problem
Pain (1994)
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Event Type
Injury
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Manufacturer Narrative
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Concomitant products: product id 3550-29, lot # n536517, implanted: (b)(6) 2015, product type accessory; product id 97740, serial # (b)(4), product type programmer, patient; product id 977a260, serial # (b)(4), implanted: (b)(6) 2015, product type lead.(b)(4).
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Event Description
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The consumer reported that an elective replacement indicator (eri) was seen.It was first seen on (b)(6) 2015.There were no trauma or falls possibly related to the issue.There were no unrelated medical procedures.It was noted that the patient also had a device from a different manufacturer but it was more than 8 inches away and the patient wondered if this could have affected her implantable neurostimulator (ins).There was an allegation/dissatisfaction with ins longevity, as the patient was just implanted in (b)(6) 2015 and now she saw the eri.It was also noted that every morning the patient would turn stimulation off when she showered, because she had pain if she lifted her arm above her head to shower.It got worse if the stimulation was on, so she would turn stimulation off.This started before she got the ins, and it also did this with her other device.The pain started on (b)(6) 2012 when she got injured.It was noted that the patient had a history of non-malignant pain.Additional information was received from the patient saw their doctor on (b)(6) 2015 with a manufacturer representative (rep) and it was found that they had used 96% of the battery and it needed to be changed.The patient was having surgery on (b)(6) 2015 and the patient asked to replace the battery because it the patient felt that they thought that maybe something was wrong with this because since then it had gone dead.The patient was in extreme pain.It was noted that the device was put in on (b)(6) 2015 and for it to already fail was unacceptable.The patient indicating that on (b)(6) the ins was replaced on (b)(6) 2015 after lasting only 8 weeks with a nonrechargeable ins.The previous ins was being sent back to be analyzed.If additional information is received, the event will be updated.
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Manufacturer Narrative
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Additional review determined the following device code is also related to this event (b)(4).
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Manufacturer Narrative
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(b)(4).
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Event Description
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Additional information received from the patient reported that there was premature depletion.The patient had high settings and the device was supposed to last 18 months but only lasted 10 weeks.Stimulation was not as strong in (b)(6) 2015.They interrogated the implantable neurostimulator (ins) on (b)(6) 2015 and 96% of the battery was used.The device was going to be sent back for analysis.It was noted that the patient had a sore throat from intubation and was on crutches.
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Event Description
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Additional information was received from the patient reported that the implantable neurostimulator (ins) was replaced because it depleted 6 weeks post implant.The ins was sent in for analysis.The patient expected the ins to last 3-5 years.The revision had occurred and the patient recovered completely.No symptoms reported.
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Search Alerts/Recalls
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