MEDTRONIC PUERTO RICO OPERATIONS CO. RESTORE SENSOR; STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
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Model Number 37714 |
Device Problems
Delayed Charge Time (2586); Battery Problem (2885); Charging Problem (2892); Connection Problem (2900); Material Integrity Problem (2978)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/24/2017 |
Event Type
malfunction
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Manufacturer Narrative
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References the main component of the system and other applicable components are: product id: 37751, serial# (b)(4), product type: recharger.Product id: 37761, serial# (b)(4), product type: recharger.Analysis of the desktop charger and the ins recharger could not verify the complaints and found no evidence of anomalies.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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Event Description
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Information was received from a manufacture representative regarding a patient implanted with an implantable neurostimulator (ins) for spinal pain.It was reported that the patient's ins was taking too long to charge and that it never charges past 25% even after charging for 2-3 hours.The reason for this issue was thought to be due to the loose connection between the desktop charger and the ins recharger (insr), both of which were reported to have bent pins.It was also reported that the patient's ins had depleted, but the rep was able to turn stimulation back on.A new insr and desktop charger were sent to the patient, who was advised to follow-up with an hcp if this did not resolve the recharging issue.No further complications were reported.
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Manufacturer Narrative
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Corrected information sex, date of birth.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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