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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 Problems Unspecified Infection (1930); Inflammation (1932); Discomfort (2330)
Event Date 07/07/2021
Event Type  Injury  
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
Event Description

Information was received from a manufacturer representative (rep) regarding a patient who was implanted with an implantable neurostimulator (ins). It was reported that patient complaining about pocket sensitivity. Patient has some inflammation over battery pocket site. Was concern of possible infection so started on antibiotic & informed to keep area clean.  antibiotics & battery site checks to confirm no heat, draining or redness. The issue is 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 Key12242658
MDR Text Key264055495
Report Number3004209178-2021-11575
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
Report Date 07/28/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/28/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
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 Received07/07/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured01/27/2021
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: 07/28/2021 Patient Sequence Number: 1
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