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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); Energy Output Problem (1431); Impedance Problem (2950)
Patient Problems Therapeutic Effects, Unexpected (2099); Insufficient Information (4580)
Event Date 08/07/2020
Event Type  Injury  
Manufacturer Narrative

Concomitant medical products: product id: neu_unknown_lead, serial#: unknown product type: lead. Other relevant device(s) are: product id: neu_unknown_lead, serial/lot #: unknown. If information is provided in the future, a supplemental report will be issued.

 
Event Description

Information was received from a patient via manufacturer representative. It was reported that patient has stim lead placed at t3. Impedences and lead connectivity showed 0-7 not connected in implantable neurostimulator (ins). Patient noticed change in coverage a month ago. Patient does not remember any fall or major twisting, however, landscaper as occupation. Actions/interventions that were taken to resolve the issue were x-ray and consult for lead revision, that will be scheduled. The issue was not resolved at the time of the report. Additional information was received from the manufacturer representative (rep). Manufacturer representative (rep) reported that the revision surgery had not been scheduled. The lead serial number could not be verified.

 
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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 Key10423215
MDR Text Key203494106
Report Number3004209178-2020-14301
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 11/30/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/18/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date10/28/2019
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 Received11/25/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured11/09/2018
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: 08/18/2020 Patient Sequence Number: 1
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