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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 Intermittent Continuity (1121); Failure to Deliver Energy (1211)
Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099); Thyroid Problems (2102); Complaint, Ill-Defined (2331); Malaise (2359)
Event Type  malfunction  
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 spinal pain via a manufacturer¿s representative (rep). The rep reported that the patient was able to charge the ins fine. The rep reported that the patient charged the controller and 3 times the ins had turned off randomly. The rep reported that when the patient looked at the controller later, sometimes the next day, the controller was not green/on for her group. It was noted that the rep wasn¿t with the patient at the time of the call. The rep reported that the patient wasn¿t feeling well and the patient would contact the rep when she was up to a meeting. It was noted that the patient¿s bowels were impacted, but trying to be managed by medication and the patient¿s thyroid level was low. The rep also reported that the ins hurt all the time with stimulation on or off. The rep reported that the pain was described as ¿ribbon around her about 2 inches above crotch level¿ and it was covered when stimulation was on. The rep reported that the patient charged in bed almost every day. The rep reported that the patient¿s ins pocket was evaluated and looked fine. The rep reported that the patient stated the ins didn¿t seem to be pressing on a bone. 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 manufacturer's representative (rep). It was determined that the patient's controller was not randomly turning it on and off but rather the patient was not understanding how to use the controller. It was reported that when the patient changed positions she believed the controller was turning off rather it just needed to be adjusted. The patient is scheduled for a f/u appt. With manufacturer to do a reprogramming. No further information.
 
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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 Key7125746
MDR Text Key95188597
Report Number3004209178-2017-26163
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 12/21/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/18/2017
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? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/19/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/19/2017
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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