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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 Problem Data Problem (3196)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/30/2020
Event Type  Malfunction  
Manufacturer Narrative

Concomitant medical products: product id: 97745, serial#: (b)(4), product type: programmer, patient. If information is provided in the future, a supplemental report will be issued.

 
Event Description

Information was received from a patient with an implantable neurostimulator (ins) for the treatment of non-malignant pain. It was re ported that the patient still got ¿device not detected¿ on the controller and the healthcare professional (hcp) had trouble finding the ins with the controller at their appointment. They reported an intermittent connection causing the charge quality to change. They moved the cable on the recharger with no effect. They verified that there was no physical damage to the recharger. The patient stated they are programmed with high density (hd) settings and could not use adaptive stimulation with hd programming. They would set the stimulation at the level they needed it and then check later and the program was changed to a different setting on its own without touching the controller. The patient stated the hcp suggested reprogramming. A replacement controller was sent. No patient complications were reported as a result of this event.

 
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
Event Description

Additional information was received from patient who reported that the ins settings changing on their own started in (b)(6) 2020 and stated that perhaps change in activity were the circumstances that led to the issue; no program changed. However, patient stated that the programming was changed at time of starting with the new controller which seems to resolved the issue. No symptoms were reported. No further complications were reported or anticipated.

 
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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
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key10130758
MDR Text Key194471464
Report Number3004209178-2020-09913
Device Sequence Number1
Product Code LGW
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/29/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/08/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/28/2019
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 Received06/22/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured05/10/2018
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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