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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 Problems Pain (1994); 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 from a manufacturer representative (rep) regarding a patient with an implantable neurostimulator (ins) for other pain indications - other. It was reported that there were high impedances on electrodes 5,6,7. It was noted that there were invalid impedance readings of "???" with electrode pairs 2<(>&<)>3, 3<(>&<)>5, 4<(>&<)>5 and 5<(>&<)>6. The rep did an impedance check and a battery check and the ins voltage was at 2. 56. The rep performed reprogramming but was unable to cover one area of pain. It was noted that the issue was not resolved at the time of the report. No further complications were reported/anticipated.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the manufacturer's representative. It was reported that the cause was not determined. Rep reported they attempted to reprogram around the lead. Only covers one of the two areas of pain. Surgeon and patient are deciding if they will have a revision.
 
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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 Key7562084
MDR Text Key109888353
Report Number1030489-2018-00793
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P840001
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 06/20/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/01/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/28/2005
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 Received06/01/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured08/05/2003
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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