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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); Patient Device Interaction Problem (4001)
Patient Problem Pain (1994)
Event Date 04/01/2021
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a patient who was implanted with an implantable neurostimulator (ins) for spinal pain. The patient reported that they thought that the implantable neurostimulator may have moved inside some muscle. The patient said they were at their physical therapy appointment and the therapist used a big ball on their back over the ins (therapist didn't realize that was where the ins was). Pt said the therapist was pushing pretty hard with the ball over the ins, which hurt, and pt said that was the only thing they could think of that could have moved the ins. Event date was asked, but pt said it was when they started therapy, and said they had been in therapy for 3 months, but later said it was probably around (b)6). The patient was redirected to their healthcare provider to further address the issue.
 
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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 Key12031388
MDR Text Key257162606
Report Number3004209178-2021-09652
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
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 06/21/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/21/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/28/2021
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 Received06/18/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/10/2020
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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