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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 Migration or Expulsion of Device (1395); Unintended Collision (1429); Energy Output Problem (1431)
Patient Problems Fall (1848); Device Overstimulation of Tissue (1991); Loss of consciousness (2418); No Known Impact Or Consequence To Patient (2692)
Event Date 08/10/2020
Event Type  Injury  
Manufacturer Narrative

Concomitant medical products: product id: 977a275, serial#: (b)(4), implanted: (b)(6) 2018, product type: lead; product id: 977a275, serial#: (b)(4), implanted: (b)(6) 2018, product type: lead. If information is provided in the future, a supplemental report will be issued.

 
Event Description

Information was received from a patient via manufacturer representative, regarding patient's implantable neurostimulator (ins). It was reported that patient passed out and fell down striking her head. Patient complained the spinal cord stimulation was malfunctioning and causing excess stimulation. Rep advised the patient to turn off the stimulation. Patient responded that she did not have her programmer with her but had a friend rush home to get it. Patient reported the device was now off. Patient will be seen in follow up and with a rep on 8/20 to assess system.

 
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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 Key10401148
MDR Text Key202705074
Report Number3004209178-2020-14005
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
Report Date 10/08/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/13/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date08/14/2019
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 Received10/01/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured08/20/2018
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 08/13/2020 Patient Sequence Number: 1
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