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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Wound Dehiscence (1154)
Event Date 08/13/2021
Event Type  Injury  
Manufacturer Narrative

Concomitant medical products: product id 977a260 lot# serial# (b)(4), implanted: (b)(6) 2021, product type lead. Product id 977a260 lot# serial# (b)(4), implanted: (b)(6) 2021. Product type lead. Other relevant device(s) are: product id: 977a260, serial/lot #: (b)(4), ubd: 04-jun-2025, udi#: (b)(4); product id: 977a260, serial/lot #: (b)(4), ubd: 16-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 manufacturer representative regarding a patient who was implanted with an implantable neurostimulator (ins). It was reported that patient was seen on friday for first post-op appointment but there were no concerns at this time, however, over the weekend patient had "hissing at the incision" which was later clarified that midline incision was open and lead is exposed. Patient was seen by surgical team and it was decided to remove lead(s) by cutting it at the midline but leave ins implanted with part of the lead until a later date to either replace full system or full explant. Caller inquired about concerns for leaving lead in. Ts reviewed that when any part of the system is removed the whole system should removed as it would be a medical decision to just remove half. Cutting lead halfway is not recommended either but they might want to cap/cover cut end some how to prevent any irritation to patient. Mri considerations were also reviewed. Ts attempted to call caller back to clarify notify date as he stated he was notified on friday of the post-op appointment and the issue began over the weekend but reached vm. Troubleshooting was not required. The troubleshooting steps that were taken on the call resolved 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 Key12330736
MDR Text Key266859053
Report Number2649622-2021-16704
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
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/10/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/17/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
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 Received08/30/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured06/01/2021
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: 08/17/2021 Patient Sequence Number: 1
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