Model Number 37800 |
Device Problem
Unstable (1667)
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Patient Problems
Staphylococcus Aureus (2058); Swelling (2091); Urinary Retention (2119); Complaint, Ill-Defined (2331)
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Event Date 12/06/2017 |
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 consumer regarding a patient with an implantable neurostimulator (ins) for gastrointestinal/pelvic floor issues.It was reported that at the patient¿s last implant, the surgeon did it outpatient (had always been inpatient), and the patient¿s friend/family member didn't think the surgery was done properly and thought a pocket was not made or the ins was not sewn in because the ins was moving around and around the ribs, maybe turned where it was wider/stuck out more, and was sticking out farther than the previous devices.The past implants were replaced due to normal battery depletion.It was noted that that the patient had problems after the surgery as well, including a little swelling and not draining; they followed up with the surgeon and eventually went to the er to have tests run/blood test to check for a staph infection.It was noted that the swelling subsided and that the patient had staph one time before at a back surgery that was unrelated to the implant.It was noted that there was not an issue with the therapy.No further complications were reported/anticipated.
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Manufacturer Narrative
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Due to (b)(6) harmonization, any previously submitted device, method, result, and conclusion codes no longer apply to this event.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 consumer regarding a patient with an implantable neurostimulator (ins).It was reported since the implant the device had not been checked and the patient was not emptying properly.The patient felt the surgeon did not implant the device right.The patient noted they had been going through a lot of problems.The patient stated they sent her home without checking if she could go to the bathroom and it caused many problems.The patient stated the surgery was a messed-up surgery.The patient noted they didn¿t know what was wrong with her.The patient stated she was the first patient for the surgeon and he didn¿t know what he was doing.There were no further complications that have been reported as a result of this event.
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Search Alerts/Recalls
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