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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 Break (1069); Migration or Expulsion of Device (1395); Energy Output Problem (1431); Patient Device Interaction Problem (4001)
Patient Problem Insufficient Information (4580)
Event Type  Injury  
Manufacturer Narrative
Other relevant device(s) are: product id: 977c165, serial/lot #: (b)(4), ubd: 15-nov-2020, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from multiple sources (manufacturer representative, healthcare provider, foreign) regarding a patient who was implanted with an implantable neurostimulator (ins) for unknown indications for use. It was reported that there was significant lead migration and lead fracture at the distal end of the lead before the paddle. Stimulation gradually reduced over time. It was noted that movement may have led or contributed to the issue. X-ray was done to see migration and fracture of the lead. The lead was removed and replaced, and the issue was resolved. The patient was alive with no injury.
 
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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 MN 00777
Manufacturer (Section G)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos,pr MN 00777
Manufacturer Contact
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key11849906
MDR Text Key251448531
Report Number2182207-2021-00844
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
P840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 08/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/19/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/14/2019
Device Model Number97715
Device Catalogue Number97715
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/10/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/04/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/18/2018
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: 05/19/2021 Patient Sequence Number: 1
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