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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 Disconnection (1171); Failure to Deliver Energy (1211)
Patient Problem Therapeutic Effects, Unexpected (2099)
Event Date 04/15/2020
Event Type  Injury  
Manufacturer Narrative

Concomitant medical products: product id: 977a260, serial#: (b)(4), implanted: (b)(6) 2018, product type: lead. Product id: 977a260, serial#: (b)(4), implanted: (b)(6) 2018, product type: lead. Other relevant device(s) are: product id: 977a260, serial/lot #: (b)(4), ubd: 31-mar-2022, udi#: (b)(4) ; product id: 977a260, serial/lot #: (b)(4), ubd: 31-mar-2022, 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 implanted with a neurostimulator (ins). It was reported that patient is not getting stimulation, but is able to recharge her implant. Connection test shows all contact connections are invalid. Hcp used flouro and one of the lead looked like it "spindled" out. Hcp is waiting for approval before revision. Issue occurred a couple months ago per patient, no known cause of lead disconnection. No further complications were reported.

 
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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 Key10236751
MDR Text Key197745491
Report Number3004209178-2020-11638
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 07/06/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/06/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/28/2019
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 Received06/12/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured03/12/2018
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: 07/06/2020 Patient Sequence Number: 1
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