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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG SYNERGY; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

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MDT SOFAMOR DANEK PUERTO RICO MFG SYNERGY; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number 7427
Device Problems High impedance (1291); Energy Output Problem (1431); Unable to Obtain Readings (1516)
Patient Problem Therapeutic Effects, Unexpected (2099)
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received by the patient via a manufacture representative (rep) regarding a patient with an implantable neurostimulator (ins).It was reported that the patient¿s stimulator was working well for a while, but the patient thought that it had died 7 to 8 years ago.They indicated that when they ran the therapy measure it displayed a value of greater than 4,000 ohms for program 2.They stated that they thought the patient was programmed on electrodes 4 and 6 in program 2.The rep ran impedances at 1.5v 210us 30hz and most values were 714 ohms and 468 ohms, but pairs 4/6 4/3 4/5 displayed a value of ??? the rep stated that they increased the intensity on program 2 to 10v before the patient felt anything.On program 1 the patient felt stimulation at 4v.The rep was not with the patient at the time of the call.The reason for the call was to ask about evaluating the impedances and how to proceed.The rep indicated that the doctor may replace the ins and they needed to know if they would have to replace the leads as well.Information was reviewed on impedances and the rep indicated that they would rerun impedances and further evaluate the system.
 
Event Description
Additional information was received from the rep.It was reported that there was still no date for battery replacement and cause remains unknown.
 
Manufacturer Narrative
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.
 
Manufacturer Narrative
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.
 
Event Description
Additional information was received from a manufacturer representative regarding the patient.It was reported that electrode 4 was confirmed to be out of range with an impedance value of greater than 4,000 ohms.
 
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Brand Name
SYNERGY
Type of Device
STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
Manufacturer (Section D)
MDT SOFAMOR DANEK PUERTO RICO MFG
barrio marianna rd 909, km0.4
humacao,pr MN 00792
MDR Report Key10388909
MDR Text Key202426632
Report Number2182207-2020-00674
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
PMA/PMN Number
P840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Type of Report Initial,Followup,Followup
Report Date 09/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/28/2003
Device Model Number7427
Device Catalogue Number7427
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 08/06/2020
Initial Date FDA Received08/10/2020
Supplement Dates Manufacturer Received08/06/2020
08/27/2020
Supplement Dates FDA Received08/25/2020
09/01/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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