MEDTRONIC PUERTO RICO OPERATIONS CO. SURESCAN; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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Model Number 97702 |
Device Problems
Therapy Delivered to Incorrect Body Area (1508); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Wound Dehiscence (1154); Bacterial Infection (1735); Purulent Discharge (1812); Unspecified Infection (1930); Undesired Nerve Stimulation (1980); Sepsis (2067); Test Result (2695)
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Event Date 06/17/2014 |
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).It was reported that the ins was removed 4-5 years prior to the report due to infection.The caller did not know the exact date.The explanting hcp was unknown.No further complications were reported.
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Event Description
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Additional information received from a healthcare professional (hcp).It was reported that the pre-operative diagnosis was a wound infection; there was an infected spinal cord stimulating electrode wiring and the battery had a positive blood culture.The lead and generator were removed and there was debridement of the thoracic wound and right flank wound with drainage, with primary closure over the drains.The estimated blood loss was under 20 milliliters (ml).It was noted that the patient was implanted on (b)(6) 2014 and was doing reasonably well, although they admitted to not using the stimulator much because, when it would stimulate, their legs would become paresthetic when they gained lumbar pain control.The patient had a few days of septicemia and blood cultures demonstrated gram-negative rods.As of (b)(6) 2014, the incision over the thoracic area opened and began draining purulent material.The patient had become somewhat septic with elevated white (blood cell) count.A removal of the system was agreed upon to treat the underlying bacteremia and septicemia.The procedure started on the battery side and the hcp opened up the previous incisional scar and encountered a brownish, discolored fluid.This was cultured for aerobic, anaerobic, and fungal cultures.The battery was explanted and all foreign material, including suture material, was removed from the incision site.The hcp debrided the interior of the incision site using rough dissection and then turned their attention to opening the previous thoracic incision, done through the incisional scar.They ellipsed the area where the patient had dehiscenced the incision at the lower end and removed the wound edges, which were sent for cultures, and encountered more purulent material.They removed the paddle electrode with no effort, seeming it was almost to be loose and free within the field.They didn¿t see any evidence of any securing connectors in the field.They then debrided the area around the interlaminar dissected region where the paddle electrode had been placed and irrigated copiously with bacitracin.The patient was doing well at the time they left the operating room.
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Manufacturer Narrative
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Concomitant medical products: product id 39565-65 lot# (b)(4) serial# implanted: (b)(6) 2014 explanted: (b)(6) 2014 product type lead.Date of event is an approximation.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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