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U.S. Department of Health and Human Services

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

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MEDTRONIC MED REL MEDTRONIC PUERTO RICO SYNERGY STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number 7427
Device Problems Therapy Delivered to Incorrect Body Area (1508); Inappropriate/Inadequate Shock/Stimulation (1574); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problems Nerve Damage (1979); Undesired Nerve Stimulation (1980); Pain (1994); Complaint, Ill-Defined (2331); Numbness (2415); Electric Shock (2554)
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 consumer regarding an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stimulation. It was reported that when their ins was implanted it worked well for a while and then the device started malfunctioning. When the ins was on it would send shocks down their legs and down different places it wasn't supposed to be. They weren't sure why the shocking occurred but stated that they lost a lot of weight and weren't sure if the weight loss moved things around. The ins was explanted but the healthcare provider (hcp) left two leads implanted and the patient wanted to know why the hcp would leave the leads in- the patient had been having problems with their lower back and they needed to perform an mri to determine the cause of the pain but they couldn't have an mri due to the leads. They were unsure if the pain in their back was caused by the leads or not. No further complications reported.
 
Manufacturer Narrative
Product id: 3889-28, lot# j0316195v, implanted: (b)(6) 2003, product type: lead; product id: 3889-28, lot# j0316195v, implanted: (b)(6) 2003, product type: lead. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a consumer regarding the patient. It was reported that the patient is currently working with a referred surgeon to explant the leads that were left in. The patient indicated that she needs the leads out because they are causing her to lose feelings in her legs and she cannot press on her left leg or else she loses feelings because it has caused nerve damage. The patient indicated that she was implanted for bladder control therapy, and not pain control. The leads were confirmed to be implanted in her sacral nerves, not her spinal cord. There were no further complications reported or anticipated.
 
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Brand NameSYNERGY
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
Manufacturer (Section D)
MEDTRONIC MED REL MEDTRONIC PUERTO RICO
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer (Section G)
MEDTRONIC MED REL MEDTRONIC PUERTO RICO
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer Contact
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key8692009
MDR Text Key147754345
Report Number3004209178-2019-11446
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 consumer
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 02/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/12/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/28/2006
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 Received02/04/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/13/2005
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: 06/12/2019 Patient Sequence Number: 1
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