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U.S. Department of Health and Human Services

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

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MEDTRONIC PUERTO RICO OPERATIONS CO. RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number 37714
Device Problems Delayed Charge Time (2586); Battery Problem (2885); Charging Problem (2892); Electromagnetic Compatibility Problem (2927)
Patient Problems Pain (1994); Loss of Range of Motion (2032); Malaise (2359)
Event Date 07/15/2016
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Product id: 97754, serial# (b)(4), product type: recharger.
 
Event Description
The manufacturer representative (rep) reported that it was taking too long to recharge. It was reported that the recharge stats from the clinician programmer reported a 2. 9, 6 days, average of 4 coupling bars. There was a report that repositioning the antenna resolved the issue. The rep was able to get 8 coupling bars and troubleshooting resolved the issue. It was reported that the rep would work with the patient on education on coupling. No symptoms were reported. Relevant medical history includes spinal pain. On (b)(6) 2016,the patient reported they are having some charging issues with their device. They stated that they have to charge all day to get their implant fully charged, but they can¿t leave it to charge all day because the recharger shows an overheating warning message. The patient further stated that their implantable neurostimulator (ins) keeps ¿shorting out. ¿ they further explained that when they take a shower, the ins battery depletes. It was noted that the patient has been charging every 12 hours for about the past 3 months. The patient mentioned their therapy hurts when they have it on. They stated they had a fall in (b)(6) 2016, but x-rays were taken of the leads and nothing unusual was found. Additionally, the patient cannot turn their neck due to ¿anchors¿ that are in their neck. The patient also mentioned that they are on so much medication that it is making them sick. The patient was to follow up with a manufacturing representative to have their device checked. The patient was implanted for spinal pain.
 
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Brand NameRESTORE SENSOR
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
Manufacturer (Section D)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer (Section G)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer Contact
diane wolf
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263987
MDR Report Key6066820
MDR Text Key102529998
Report Number3004209178-2016-22852
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,consum
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/31/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/31/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/28/2016
Device Model Number37714
Device Catalogue Number37714
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 Received10/25/2016
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured08/05/2015
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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