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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MDT PUERTO RICO OPERATIONS CO, MED REL SYNERGY STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

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MDT PUERTO RICO OPERATIONS CO, MED REL SYNERGY STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number 7427
Device Problems Failure to Deliver Energy (1211); Unable to Obtain Readings (1516); Device Displays Incorrect Message (2591)
Patient Problem Therapeutic Effects, Unexpected (2099)
Event Date 07/28/2017
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a manufacturer's representative (rep) regarding an implantable neurostimulator (ins) for the treatment of post laminectomy pain. It was reported that the patient had impedances with 435-20134 with some "?" marks. The patient reported that their stimulation stopped eight months ago. The rep checked with the 8840 and discovered that a por had occurred. The rep cleared the por and checked impedances. The rep will try to reprogram the device. No further complications were reported or anticipated.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a manufacturer's representative (rep). It was reported that the cause of the por was unknown. The actions taken to resolve the por was the patient being reprogrammed. The patient was reportedly scheduling a replacement. The stimulation stopping has been resolved. No further complications were reported or anticipated.
 
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Brand NameSYNERGY
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
Manufacturer (Section D)
MDT PUERTO RICO OPERATIONS CO, MED REL
road 909, km. 0.4., barrio mar
humacao PR 00792
Manufacturer (Section G)
MDT PUERTO RICO OPERATIONS CO, MED REL
road 909, km. 0.4., barrio mar
humacao PR 00792
Manufacturer Contact
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key7388526
MDR Text Key104141776
Report Number2647346-2018-00007
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 04/22/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/02/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/28/2004
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 Received04/02/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/09/2003
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/02/2018 Patient Sequence Number: 1
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