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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); High impedance (1291)
Patient Problems Therapeutic Effects, Unexpected (2099); No Known Impact Or Consequence To Patient (2692)
Event Date 07/02/2020
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 patient via manufacturer representative, regarding patient's implantable neurostimulator (ins). It was reported that patient had an ipg replacement on (b)(6) 2020. During enter up testing, all of her connections and impedances were fine. Upon seeing her on 7/2 and reading her battery, all the impedances and connections on lead 0-7 were bad. For now, the rep programmed on her other lead and stopped using the lead in question. The hcp ad no further information. Additional information received from a manufacturer representative (rep). The leads had high impedance. Te cause was not determined. The rep programmed the other lead and that seems to be working well for now. No further complications were reported.

 
Manufacturer Narrative

Concomitant medical products: product id: 977a275, serial#: (b)(4), implanted: (b)(6) 2017, product type: lead. Product id: 977a275, serial#: (b)(4), implanted: (b)(6) 2017, product type: lead. If information is provided in the future, a supplemental report will be issued.

 
Event Description

Additional information was received from a manufacturer representative and a consumer regarding the patient. Upon interrogation on (b)(6) 2020, both lead connectivity and impedances read all green and usable. The patient was unable to feel any stimulation even at the highest settings on the 0-7 lead. The manufacturer representative reprogrammed the patient onto the 8-15 lead. X-rays were taken and showed that one lead is out of the channel and disconnected. There is a plan for surgical intervention to reattach the lead and gain coverage with the 0-7 lead. The surgery is scheduled for (b)(6) 2020. The implantable neurostimulator will be replaced. There were no further complications 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 Key10245870
MDR Text Key197983368
Report Number3004209178-2020-11788
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,CONSUM
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 10/08/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/08/2020
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?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/08/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured05/22/2020
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: 07/08/2020 Patient Sequence Number: 1
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