MEDTRONIC MED REL MEDTRONIC PUERTO RICO SYNERGY; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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Model Number 7427 |
Device Problems
Failure to Deliver Energy (1211); High impedance (1291); Unable to Obtain Readings (1516); Battery Problem (2885); Electromagnetic Compatibility Problem (2927); Insufficient Information (3190)
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Patient Problems
Therapeutic Effects, Unexpected (2099); Discomfort (2330)
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Event Date 10/18/2019 |
Event Type
malfunction
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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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Information was received from a consumer regarding a patient with an implantable neurostimulator (ins) for arachnoiditis.It was reported that the patient was advised to contact the manufacturer to schedule a rep to come to the hcp office to check the patient's ins.The caller said the patient's ins hasn't worked since he had his heart shocked out of a-fib.The caller said it was working prior to the procedure.The caller said the patient's back started to really bother them the night prior to the report.The patient could not feel stim, so they tried increasing it with the programmer but the efforts were unsuccessful.The caller said they saw 2 green lights and 1 yellow on the programmer.It was reviewed the ins was off.The patient turned on the ins and confirmed that all 3 green lights were lit.The patient tried to increase stimulation and hears 3 audible beeps, indicating that he likely reached the maximum range set by the hcp.The patient said he still could not feel stimulation.No further complications were reported.
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Manufacturer Narrative
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Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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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Additional information received from a manufacturer representative (rep).It was reported that the rep was seen post cardioversion.The caller reported when she interrogated the ins, a por message appeared.The rep saw 0v/210pw/30hz with electrode 0-3+ 4-7+.The rep said the patient was feeling stim.Impedances showed: 1/2 ???, ok impedance: 1/3 ,1/4,1/6,1/7,2/3,2/4,2/5, reports all contact pairs with 0 shows >4k ohms.The impedances read at 3v/300pw showed: 1: 2-3+ ???, 2.4-7+: 954 ohms 25ua.The rep said the ins battery measured 2.64v and ok.The capacity was 35/70.The rep said the por was cleared and the patient was reprogrammed for therapy optimization.The issue was said to be resolved.No further complications were reported.
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