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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

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MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR Back to Search Results
Model Number 97715
Device Problems Overheating of Device (1437); Delayed Charge Time (2586); Charging Problem (2892); Insufficient Information (3190)
Patient Problems Burn(s) (1757); Burning Sensation (2146)
Event Date 01/01/2021
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: product id 97755 lot# serial# (b)(4) implanted: explanted: product type recharger. Information references the main component of the system. Other relevant device(s) are: product id: 97755, serial/lot #: (b)(4) , ubd: , udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a patient (pt) regarding an external device. The reason for call was starting early 2021 the pt has had a "horrible' time charging their implant. Pt mentioned that it could take them all day to charge their implant and that they would get messages to try again. Pt mentioned that the rtm cord near the antenna started to burn (pt mentioned that it was not warm enough to leave a blister) during implant recharge. Pt mentioned that the rtm paddle felt like something was broken. Pt mentioned that they were still able to charge their controller. Additional information received reported pt called back reporting that they haven't received their replacement recharger. Ps consulted with repair and repair confirmed it was mistakenly not sent out. Ps reviewed with pt that they can expect the replacement recharger tomorrow. It was reported that the charge for their implanted battery was replaced. It replaced a charger that may have had a broken wire and failed to charge their battery and caused burns on skin.
 
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Brand NameINTELLIS
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
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 Key11922918
MDR Text Key267298243
Report Number3004209178-2021-08711
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,Followup
Report Date 06/16/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/02/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/14/2019
Device Model Number97715
Device Catalogue Number97715
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/12/2021
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/10/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/26/2018
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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