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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.

 
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Brand NameSYNERGY
Type of DeviceSTIMULATOR, 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
Manufacturer (Section G)
MDT SOFAMOR DANEK PUERTO RICO MFG
barrio marianna rd 909, km0.4
humacao,pr MN 00792
Manufacturer Contact
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key10388909
MDR Text Key202426632
Report Number2182207-2020-00674
Device Sequence Number1
Product Code LGW
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 09/01/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/10/2020
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
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/27/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured12/10/2001
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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