Model Number 37800 |
Device Problems
Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Wound Dehiscence (1154); Hematoma (1884); Unspecified Infection (1930)
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Event Date 08/23/2019 |
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) via a manufacturer representative regarding a patient with an implantable neurostimulator (ins) for gastric stimulation.It was reported that the patient developed a hematoma after a battery change due to stopping their blood thinner too early.A pocket revision was performed and the issue was resolved at the time of the report.No further complications were reported/anticipated.
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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) via a manufacturer representative.It was reported that the generator was moving around the pocket and the patient was taken back into the or on (b)(6)2019 to re-secure the generator to the abdominal wall.The patient came back in for follow up and had removed some of the staples themselves and there was a small opening; the patient was sent home with wound care instructions.The patient returned to the clinic on (b)(6)2019 and the wound had opened up some more.The hcp put a q-tip in the wound and touched the generator, so they had decided to remove the generator before the area became infected and was planning on taking it out within the next week or two.No further complications were reported/ anticipated.
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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 received from a healthcare professional (hcp) via a manufacturer representative (rep).It was reported that the patient developed an infection and had their battery removed on (b)(6) 2019.The hcp left the leads in the patient¿s abdomen and was going to place a new battery on the opposite side of the patient¿s body on (b)(6) 2019.
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Search Alerts/Recalls
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