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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 97716
Device Problems Migration or Expulsion of Device (1395); Unintended Collision (1429); Therapy Delivered to Incorrect Body Area (1508)
Patient Problems Pain (1994); Burning Sensation (2146); Inadequate Pain Relief (2388)
Event Type  Malfunction  
Manufacturer Narrative

Concomitant medical products: product id: 977a260, serial# (b)(4), implanted:(b)(4). Product type lead product id 977a260, serial# (b)(4), implanted: (b)(6) 2021. Other relevant device(s) are: product id: 977a260, serial/lot #: (b)(4), ubd: 12-apr-2025, udi#: (b)(4); product id: 977a260, serial/lot #: (b)(4), ubd: 12-apr-2025, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.

 
Event Description

Information was received from a patient (pt) via manufacturer representative (rep) who was implanted with an implantable neurostimulator (ins). It was reported that patient had lack of pain relief and burning sensation along spine.  patient had a fall.  interrogated battery. Normal impedances and no errors. X-ray taken. Both leads came down a level.  reprogrammed with new lead location. The issue was not resolved.

 
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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 Key12362094
MDR Text Key267958102
Report Number3004209178-2021-12857
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 09/03/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/24/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number97716
Device Catalogue Number97716
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/24/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured04/14/2021
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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