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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 Computer Software Problem (1112); Overheating of Device (1437); Charging Problem (2892)
Patient Problems Burn(s) (1757); Burning Sensation (2146); Discomfort (2330); Skin Inflammation (2443)
Event Date 01/24/2020
Event Type  Malfunction  
Manufacturer Narrative

Concomitant medical products: product id: 97745, serial#: (b)(4), product type: programmer, patient. Product id: 97755, serial#: (b)(4), product type: recharger. Other relevant device(s) are: product id: 97755, serial/lot #: (b)(4), udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.

 
Event Description

Information was received from a consumer and a manufacturing representative regarding a patient with an implantable neurostimulator (ins) for non-malignant pain. It was reported that the controller showed software problem 1-intellis, 2-3. 0, 3-243, 4-qf_port when the patient was charging. The issue had been going on since (b)(6) 2020 and the controller would be unresponsive when they hit the buttons. Resetting resolved the issue. The ins was 100% charged and the controller was 60% charged. It was further reported that when the patient went to charge their ins they burned themselves with the recharger at the battery site. They initially stated that the recharger wasn't hot to the touch, but later stated that it felt like it was very hot and was uncomfortable. When they removed the recharger from their skin they had a deep red blister and a red mark. They then reported they had issues with the software problem and the system being slow. It took 45 minutes to initiate the charging process and the controller kept shutting off while trying to charge the ins. They kept getting three of the same errors. No further complications were reported or anticipated.

 
Manufacturer Narrative

Product id 97745, serial# (b)(4). Product type programmer, patient, product id 97755, serial# (b)(4). Product type recharger. If information is provided in the future, a supplemental report will be issued.

 
Event Description

Additional information received stated that the patient had the recharge telemetry module in their pocket against the skin, and the recharge telemetry module coil became hot, the patient felt stinging, and noticed redness and blistering. The patient also reported error messages and the recharge telemetry module shutting off. The patient confirmed returning the recharger. The patient stated they received the new recharge telemetry module and have had no issues since. Patient weight is (b)(6).

 
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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 Key9717247
MDR Text Key179760359
Report Number3004209178-2020-03469
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 COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/19/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/17/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date10/28/2019
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 Received05/14/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/04/2018
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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