Model Number 97713 |
Device Problems
Break (1069); Intermittent Continuity (1121); Failure to Deliver Energy (1211); Malposition of Device (2616); Battery Problem (2885); Protective Measures Problem (3015); Insufficient Information (3190)
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Patient Problems
Seroma (2069); Discomfort (2330); Impaired Healing (2378); Fluid Discharge (2686); Patient Problem/Medical Problem (2688)
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Event Date 06/01/2018 |
Event Type
Injury
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Manufacturer Narrative
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Information references the main component of the system and other applicable components are : product id: neu_unknown_lead, lot# unknown, product type: lead.Information references the main component of the system.Other relevant device(s) are: product id: neu_unknown_lead, serial/lot #: unknown, ubd: , udi#:.If information is provided in the future, a supplemental report will be issued.
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Event Description
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The healthcare professional reported repeated unintended switch off events.There were no external factors known.No diagnostics or troubleshooting was performed.No interventions/actions were taken.It was unknown if the issue was resolved at the time of report.The patient stated that the device sometimes was stopping it work without making anything.The patient has had a lot of revision in the past two years, including changing the leads or the place of the leads, connecting to the implantable neurostimulator (ins).The revisions were sore.The device data showed that the was a parity power on reset (x400) on (b)(6) 2018.Apart from that there was no abnormalities visible, no overdischarges, and no therapy loss with stimulation on.There have been up to four revisions without changing the system.Two time for changing the leads.The last lead changing had been in february.The surgeon tried to replace the lead and it was damaged.
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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 the manufacturer representative (rep).It was reported that the revision was because of the placement of the lead and during this surgery it had been damaged.There had been no problem with the lead before.
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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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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 the manufacturer representative (rep).It was reported that the revision was because of the placement of the lead and during this surgery it had been damaged.There had been no problem with the lead before.(b)(4) 2018 (rep, for): additional information was received from the rep.It was reported that the revisions had not been reported to the manufacturer because the they were not problems with the system.They had been problems with the healing, and wound fluid/seromas.There had only been one replacement after trying to change the placement of the surgical lead.It was damaged while uncovering it.
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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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Manufacturer Narrative
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Note that section d information references the main component of the system and other applicable components are: product id: 977c190, lot#: va18r3u013, implanted: (b)(6) 2017, explanted: (b)(6) 2018, product type: lead.Additional information clarified that there was only one lead that was revised, not two as previously reported.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 the rep.It was noted that the first implant was done with a 5-6-5 configuration surgical lead on (b)(6) 2017.The replacement was done on (b)(6) 2018 with another of the same model lead which is still implanted as of (b)(6)2018.
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Search Alerts/Recalls
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