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U.S. Department of Health and Human Services

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

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MEDTRONIC MED REL MEDTRONIC PUERTO RICO RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number 37714
Device Problems Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abscess (1690); Staphylococcus Aureus (2058); Fluid Discharge (2686)
Event Date 03/30/2012
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 patient regarding their implantable neurostimulator (ins) for non-malignant pain and failed back surgery syndrome. Information was reported that the patient had a (b)(6) infection ((b)(6)). The patient stated that her spinal cord stimulator (scs) battery had flipped "not even 3 months after the surgery (confirmed sometime in 2012), so they went to flip it back in (b)(6) 2012 and then they flipped it back. Then in (b)(6) or early (b)(6) the patient ended up with an abscess and (b)(6) so they took it out". The patient said the abscess and (b)(6) was first found "towards the end of (b)(6) or early (b)(6) in 2013 and the patient had to go to the er because of the abscess. The patient said the ins was then taken out at this time, again stating "the end of (b)(6) or into the first week in (b)(6) 2013. The patient had their full system explanted. No further complications were reported. No additional patient symptoms were reported.
 
Manufacturer Narrative
Product id: 3777-45, serial# (b)(4), implanted: (b)(6) 2012, explanted: (b)(6) 2013, product type: lead; product id: 3777-45, serial# (b)(4), implanted: (b)(6) 2012, explanted: (b)(6) 2013, product type: lead. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was reported that the patient's system was removed on (b)(6) 2013. The patient developed drainage from her lead which was obviously infected. The patient failed to respond to oral antibiotics. The patient tolerated the system removal well and the patient returned to the recovery room in stable and satisfactory condition. No further information was reported.
 
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Brand NameRESTORE SENSOR
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
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key8623700
MDR Text Key145501221
Report Number3004209178-2019-09884
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,health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/20/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/28/2013
Device Model Number37714
Device Catalogue Number37714
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/22/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/07/2012
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: 05/20/2019 Patient Sequence Number: 1
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