MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
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Model Number 37603 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Unspecified Infection (1930)
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Event Date 03/20/2015 |
Event Type
Injury
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Event Description
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It was reported that the lead was removed for some type of infection in the brain.The infection had occurred on (b)(6) prior to the date of this report.The healthcare professional was inquiring about an mri with only the extension and implantable neurostimulator (ins) in place.No outcome was provided.Further follow-up is being conducted to obtain this information.If additional information is received a supplemental report will be submitted.
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Manufacturer Narrative
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Concomitant medical products: product id: unknown, serial# unknown, product type: extension.Product id: 3389s-40, lot# va0qbqv, implanted: (b)(6) 2015, explanted: (b)(6) 2015, product type: lead.(b)(4).
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Manufacturer Narrative
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Concomitant medical products: product id: 3708660, serial# (b)(4), implanted: (b)(6) 2015, explanted: (b)(6) 2015, product type: extension.Product id: 3389s-40, lot# va0qbqv, implanted: (b)(6) 2015, explanted: (b)(6) 2015, product type: lead.The initial mdr was filed as manufacturing report #3007566237-2015-01344.Additional review showed the correct manufacturing site was site #(b)(4).
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Event Description
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Additional information received from the healthcare provider (hcp) reported that the patient had an infection and the lead and extension were removed on (b)(6) 2015.Only the battery was left in the patient's body.The patient had not received a new battery as of (b)(6) 2015.
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Search Alerts/Recalls
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