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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); Inappropriate/Inadequate Shock/Stimulation (1574); Battery Problem (2885); Charging Problem (2892); Communication or Transmission Problem (2896); Connection Problem (2900); Insufficient Information (3190)
Patient Problems Burn(s) (1757); Electric Shock (2554); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/01/2021
Event Type  Malfunction  
Manufacturer Narrative

Continuation of concomitant 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#: unk. Date is approximate.

 
Event Description

Information was received from a patient via manufacturer representative who was implanted with an implantable neurostimulator (ins) for unknown indications for use. It was reported that the patient was having issues with charging "a while" later clarified as within (b)(6) 2021, maybe about a week ago. The patient stated the stimulator is depleted and they are unable to charge the stimulator. The patient stated the recharger (rtm) cord is pulling out of the paddle and shocked the patient when they were trying to charge. The patient stated they recharger got so hot that the relay box burned their stomach. The patient mentioned it has been difficult to keep a connection to charge and they hold the recharger in place to try and keep the charging session going. The patient also reported seeing rm03 during this time of issues with charging.  an email was sent to the repair department to replace the rtm. The patient stated they were told they could not have an mri but the stimulator was depleted so mri mode was unable to be used to confirm eligibility during the call. Mri information was reviewed and the brochure was emailed to the patient with instructions how to access mri mode and the meaning of the icons.

 
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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 Key12367715
MDR Text Key268149311
Report Number3004209178-2021-12919
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
Report Date 08/25/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/25/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
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 Received08/23/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured09/18/2019
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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