MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-20 |
Device Problems
Patient-Device Incompatibility (2682); Insufficient Information (3190)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
Injury
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Manufacturer Narrative
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Concomitant medical products: product id: 8703w, lot#: l37850, implanted: (b)(6) 1996, product type: catheter.Other relevant device(s) are: product id: 8703w, serial/lot #: (b)(4), udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
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Event Description
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On (b)(6) 2018, information was received from an healthcare professional (hcp) via a manufacturer representative (rep) regarding a patient receiving an unknown drug (unknown dose and concentration) via an implantable pump for non-malignant pain.On (b)(6) 2018, the rep was notified by the hcp that the patient was scheduled for a catheter revision for tomorrow ((b)(6) 2018).No further information was known.
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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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On 2018-aug-07, additional information was received from a manufacturer representative (rep).Additional information received reported that the case was postponed and "no date for future was given" by the office.The reason for the revision was unknown.The patient symptoms were unknown.
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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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Search Alerts/Recalls
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