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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 PAIN RELIEF

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MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number 97715
Device Problems Break (1069); High impedance (1291); Connection Problem (2900)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/09/2020
Event Type  Malfunction  
Manufacturer Narrative

Concomitant medical products: product id: 3777-60, serial#: (b)(4), implanted: (b)(6) 2012, product type: lead. Product id: 3777-60, serial#: (b)(4), implanted: (b)(6) 2012, product type: lead. Other relevant device(s) are: product id: 3777-60, serial/lot #: (b)(4), ubd: 28-apr-2014, udi#: (b)(4); product id: 3777-60, serial/lot #: (b)(4), ubd: 23-sep-2014, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.

 
Event Description

Information was received by a healthcare provider (hcp) via a manufacture representative (rep) regarding a patient with an implantable neurostimulator (ins). It was reported that during the patient¿s normal battery replacement due to eri, the physician had difficulties reinserting leads into the new ins. It was reported that the leads were swollen. It was indicated that impedances were checked prior to the procedure and were all within normal limits. However, after the leads where stationed in the new ins, when impedances were checked, electrodes 8 and 12 were greater than 4 ,000 ohms. There were no external or environmental factors that may have led or contributed to the issue. It was reported that the physician had made several attempts to reseat the leads into the new ins, and each time one of the leads (unknown which lead serial number) was inserted, between 2-8 electrodes had impedances that were greater than 4,000 ohms. It was indicated that the patient¿s doctor decided to leave the leads as is. The issue was resolved at the time of the report. No further complications were reported/anticipated.

 
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Brand NameINTELLIS
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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 Key10267601
MDR Text Key198748001
Report Number3004209178-2020-12074
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,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 07/13/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/13/2020
Is This An Adverse Event Report? No
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? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/09/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured04/07/2020
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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