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U.S. Department of Health and Human Services

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

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MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number 97715
Device Problems Failure to Deliver Energy (1211); Unintended Collision (1429); Overheating of Device (1437); Battery Problem (2885); Charging Problem (2892); Insufficient Information (3190); Patient Device Interaction Problem (4001)
Patient Problems Dyspnea (1816); Headache (1880); Muscle Spasm(s) (1966); Muscle Weakness (1967); Nausea (1970); Neuropathy (1983); Pain (1994); Therapeutic Effects, Unexpected (2099); Vomiting (2144); Tingling (2171); Dizziness (2194); Discomfort (2330); Complaint, Ill-Defined (2331); Malaise (2359); Loss of consciousness (2418); Ambulation Difficulties (2544); Lethargy (2560); Alteration In Body Temperature (2682)
Event Date 11/20/2017
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 patient who was implanted with an implantable neurostimulator (ins) for non-malignant pain. The patient reported that nothing seemed to be working when she turned it on and the battery on the inside had been off for the last week and a half. The patient also reported that she was feeling dizzy. No further complications were reported.
 
Manufacturer Narrative
Product id: 97745, serial# unknown, product type: programmer, patient. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the patient. They stated the controller connector does not work. No further complications were reported.
 
Manufacturer Narrative
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¿s device has not been working correctly for the last couple of months and that a manufacturer representative turned her device off almost two months prior to the report. The patient has had multiple medical issues because of the device being off. The patient had tried to connect to the implantable neurostimulator but was getting screen 15 (looking for a device). There were no further complications reported.
 
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Brand NameINTELLIS
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
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key8394200
MDR Text Key137960468
Report Number3004209178-2019-04581
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,Followup
Report Date 10/02/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/06/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/14/2018
Device Model Number97715
Device Catalogue Number97715
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/24/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/15/2017
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: 03/06/2019 Patient Sequence Number: 1
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