MEDTRONIC PUERTO RICO OPERATIONS CO. SURESCAN; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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Model Number 97713 |
Device Problems
Mechanical Problem (1384); Insufficient Information (3190); Data Problem (3196)
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Patient Problem
Therapeutic Effects, Unexpected (2099)
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Event Date 08/02/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Concomitant medical products: product id: 97740, serial#: (b)(4), product type: programmer, patient.Other relevant device(s) are: product id: 97740, serial/lot #: (b)(4), udi#: (b)(4).Analysis of the programmer (serial #: (b)(4)) found that the digital boards were corroded and the device was scrapped.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 patient.It was reported that the programmer was damaged and had gotten wet, as the patient dropped it into a toilet and tried to dry it out.The patient further explained that after they dropped it in the toilet, they started getting a ¿006¿ error code.The patient stated that they later tried to use the programmer, but instead of stimulation going up, it went negative.No out of box failures were reported.The patient was redirected to the repair department and a replacement programmer was requested.No further complications were reported or anticipated.Indication for use is non-malignant pain.
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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 patient.It was reported that the issue had resolved.Replacement was sent.No further complications were reported.
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Manufacturer Narrative
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Concomitant medical products: product id 97740 serial# (b)(4).Product type programmer.
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Search Alerts/Recalls
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