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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 Problem Migration or Expulsion of Device (1395)
Patient Problems Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/27/2021
Event Type  Injury  
Manufacturer Narrative

Concomitant medical products: product id: 977a260, lot#: none, serial# (b)(4), implanted: (b)(6) 2018, explanted: none, product type; lead. Product id: 977a260, lot#: none, serial# (b)(4), implanted: (b)(6) 2018, explanted: none, product type: lead. Other relevant device(s) are: product id: 977a260, serial/lot #: (b)(4), ubd: 22-oct-2022, udi#: (b)(4). Product id: 977a260, serial/lot #: (b)(4), ubd: 11-sep-2022, udi#: (b)(4). 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 non-malignant pain. The reason for call was pt reported the leads have moved around in her back since about 6 months ago - pt stated she had an mri the other day to check the position. Pt stated the revision procedure is scheduled for (b)(6) 2021 - pt has an appt with hcp to talk about the procedure (b)(6) 2021. Pt stated dr john edwards is going to do the procedure. The patient was redirected to their healthcare provider to further address the issue. No patient symptoms were reported.  .

 
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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 Key12249196
MDR Text Key264319559
Report Number3004209178-2021-11650
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 CONSUMER
Reporter Occupation
Type of Report Initial
Report Date 07/29/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/29/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date10/14/2019
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 Received07/27/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured10/25/2018
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: 07/29/2021 Patient Sequence Number: 1
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