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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 High impedance (1291); Unable to Obtain Readings (1516)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/28/2019
Event Type  Malfunction  
Manufacturer Narrative

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

 
Event Description

Information was received from a manufacturer¿s representative (rep) regarding a patient who was implanted with an implantable neurostimulator (ins). The rep reported that the existing extension were connected to the ins and the check connectivity showed 6 green and 2 red x¿s on each lead (contacts 6, 7, 14 and 15). The rep reported that the hcp disconnected the extensions, wiped off and dried off the lead, reconnected and tightened the set screw but then the check connectivity showed all red x¿s on all 16 contacts. The rep reported that at one point the extension tails were switched in the ins ports and the same contacts showed red x¿s. The rep reported that when all contacts showed red x¿s, the electrode impedance was done and everything showed over 10,000 ohms. The rep then connected the extensions to a wireless external neurostimulator (wens) and everything was fine, around 500 ohms as it was in pre-operative. The rep switched the extension tailed were switched in the wens ports and the values remained similar. It was reviewed the put the extensions back in the ins and run electrode impedance at 3v, but the rep indicated that the surgeon probably didn¿t want to do that. No further complications were reported.

 
Manufacturer Narrative

Analysis of the implantable neurostimulator (b)(4) found no anomalies. If information is provided in the future, a supplemental report will be issued.

 
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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 MN 00777 1200
Manufacturer (Section G)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos,pr MN 00777 1200
Manufacturer Contact
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key8955404
MDR Text Key156277648
Report Number3007566237-2019-01872
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,Followup,Followup
Report Date 01/24/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/03/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date05/28/2020
Device MODEL Number97715
Device Catalogue Number97715
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/25/2019
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/23/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/30/2019
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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