BOSTON SCIENTIFIC NEUROMODULATION PRECISION SPECTRA; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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Model Number SC-1132 |
Device Problems
Overheating of Device (1437); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Cardiopulmonary Arrest (1765); Stroke/CVA (1770); Unspecified Infection (1930); Paralysis (1997); Seizures (2063); Sepsis (2067); Coma (2417); No Code Available (3191)
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Event Date 06/06/2017 |
Event Type
Injury
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Manufacturer Narrative
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Explant date: approximately (b)(6) 2017.
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Event Description
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A report was received that the patient claims that approximately four years after being implanted she was hospitalized and in a coma for 55 days, and had four blood transfusions while on life support.During this time the patients heart stopped and a temporary pacemaker was implanted.The patient also reported that she developed methicillin-resistant (b)(6) , meningitis, and sepsis.The patient underwent an explant procedure and received iv vancomycin for six months for infection.In addition, she stated she was bed ridden and spent six months in a nursing home.Due to the scar tissue that resulted from the infection, the patient now has lost that ability to move and has difficulty walking and sleeping.Patient also has hearing and memory loss.
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Manufacturer Narrative
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(b)(6).Additional information received: physician does not think that the infection was device related as the patient was septic.All devices have been explanted and nothing will be returned.He further states that the implanted device was not helping with her pain.Additional suspect medical device components involved in the event: model: sc-4316, serial/lot: (b)(4), description: clik anchor.Model: sc-8216-70, serial/lot: (b)(4), description: artisan lead 70cm.As the device involved in the complaint has not been returned, the complaint investigation site (cis) could not perform a device analysis.However, a review of the complaint report, device history record, and sterilization record were found to be satisfactory and did not find any anomalies or deviations that potentially relate to the reported event; there is no reason to suspect a manufacturing defect as the source of the reported complaint.Explant date: approximately (b)(6) 2017.
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Event Description
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A report was received that the patient claims that approximately four years after being implanted she was hospitalized and in a coma for 55 days, and had four blood transfusions while on life support.During this time the patients heart stopped and a temporary pacemaker was implanted.The patient also reported that she developed (b)(6), meningitis, and sepsis.The patient underwent an explant procedure and received iv vancomycin for six months for infection.In addition, she stated she was bed ridden and spent six months in a nursing home.Due to the scar tissue that resulted from the infection, the patient now has lost that ability to move and has difficulty walking and sleeping.Patient also has hearing and memory loss.
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Event Description
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It was reported was received that the patient claims that approximately four years after being implanted she was hospitalized and in a coma for 55 days, and had four blood transfusions while on life support.During this time the patients heart stopped and a temporary pacemaker was implanted.The patient also reported that she developed methicillin-resistant staphylococcus aureus, meningitis, and sepsis.The patient underwent an explant procedure and received iv vancomycin for six months for infection.In addition, she stated she was bed ridden and spent six months in a nursing home.Due to the scar tissue that resulted from the infection, the patient now has lost that ability to move and has difficulty walking and sleeping.Patient also has hearing and memory loss.Additional information was received that the physician does not think that the infection was device related as the patient was septic.All devices have been explanted and nothing will be returned.He further states that the implanted device was not helping with her pain.Additional information was received from the patient that the devices would overheat inside her back and buttocks.She further stated that the infection also affected her neck, shoulder, back, wrists, and gall bladder.Patient had to have breast reduction surgery and shoulder reversal implant.She additionally stated that she had the stimulator removed and died on the operating table, and suffered from a stroke and seizures.
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