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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 Overheating of Device (1437)
Patient Problems Burning Sensation (2146); Injury (2348); Numbness (2415); Skin Inflammation (2443)
Event Date 05/10/2020
Event Type  Malfunction  
Manufacturer Narrative

Concomitant medical products: product id: 97755, serial#: (b)(4), product type: recharger. Product id: 97745, serial#: (b)(4), product type: programmer, patient. 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 manufacturer representative regarding a patient with an implantable neurostimulator ( ins). It was reported that the patient noticed a blister on their skin, near the ins site, where the charging cord would sit during recharge. They had recharged on (b)(6) 2020 and (b)(6) 2020 to 100% and they stated they felt what they thought was a blister at the ins site. The patient went to the emergency room and the doctor started them on bactrim in case of cellulitis. They denied any heating/warmth at the ins site during the charge cycle. It was further reported that they didn't have much sensation in the implant area, so they didn't feel it getting hot. They would be returning the controller with the recharger that caused the injury. The manufacturer representative called in regards to the heating sensation and the blister at the ins site. The caller indicated that the patient had seen a healthcare provider about the issue and was prescribed antibiotics in case of cellulitis. 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 Key10099142
MDR Text Key193425272
Report Number3004209178-2020-09328
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 08/18/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/28/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date05/28/2020
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 Received08/10/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/04/2019
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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