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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); Unable to Obtain Readings (1516)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/11/2019
Event Type  Malfunction  
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
Event Description

Rep reported that patient's weight was unknown. No further complications were reported.

 
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
Event Description

Information was received by a manufacturing representative (rep) regarding a patient with an implantable neurostimulator (ins) for other chronic/intract pain (trunk/limbs). Information was reported that the rep wanted assistance to check and interpret the patient's impedances results: 01 1744 02 862 03 1161 04 990 05 1161 06 1161 07 3541 12 1400 13 ? 14 ? 15 2354 16 2354 17 3541 23 862 24 990 25 990 26 1161 27 3541 34 1161 35 ? 36 1161 37 3541 4 volts 450pw impedance test 07 4000 17 4000 37 4000 it was reviewed that electrode 7 appears to have a possible open circuit, the other impedance results look fine. The patient is needing a new ins. Their current program 1+2-3+ 330pw 30hz, 5 volts, looks like it would accommodate to patient's needs since electrode 7 isn't needed. No further complications were reported. No patient symptoms were reported. Additional information was received from the manufacturer representative (rep) 2019-12-16. It was reported that the cause of the impedance issue was unknown. It was not in the area of programming. No further complications were reported/anticipated.

 
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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 00792
Manufacturer (Section G)
MDT SOFAMOR DANEK PUERTO RICO MFG
barrio marianna rd 909, km0.4
humacao PR 00792
Manufacturer Contact
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key9541113
MDR Text Key176343205
Report Number1030489-2020-00012
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
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/23/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/02/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/28/2002
Device MODEL Number7427
Device Catalogue Number7427
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/02/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured01/31/2001
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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