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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 Migration or Expulsion of Device (1395); Unintended Collision (1429); Patient Device Interaction Problem (4001)
Patient Problem Insufficient Information (4580)
Event Date 10/01/2020
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: 977a260, serial#: (b)(4), implanted: (b)(6) 2020, product type: lead. Product id: 977a260, serial#: (b)(4), implanted: (b)(6) 2020, product type: lead. Other relevant device(s) are: product id: 977a260, serial/lot #: (b)(4), ubd: 16-jul-2023, udi#: (b)(4); product id: 977a260, serial/lot #: (b)(4), ubd: 16-jul-2023, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
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's trial went very well and he was super happy and pleased. But since the implant he said it has never worked. He is not getting the back pain relief he got during the trial.  patient told the rep he played golf shortly after implant. The patient said it was about 6 weeks after and he told another rep he played golf about 3-4 weeks after the implant. He was also in a bad car accident about 2 weeks ago.  x-ray taken today showed both leads have moved down 1-1. 5 vertebral levels. During the trial & at the time of implant leads were at the top of t8 and now they are at the top of t9. The rep tried reprogramming today and he is going to try the 2 new programs over the next few days. If that doesn't work the doctor is planning on referring him for a lead revision and possibly a paddle lead. Surgical intervention has been planned, but not scheduled.
 
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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
glen belmer
7000 central avenue ne rcw215
minneapolis, MN 55432
6122713209
MDR Report Key11790368
MDR Text Key249466496
Report Number2649622-2021-09209
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 Consumer,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup,Followup
Report Date 06/29/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/07/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/28/2021
Device Model Number97715
Device Catalogue Number97715
Was Device Available for Evaluation? No
Date Manufacturer Received06/21/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/01/2020
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: 05/07/2021 Patient Sequence Number: 1
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