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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

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MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR Back to Search Results
Model Number 97715
Device Problems Energy Output Problem (1431); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Headache (1880); Inflammation (1932); Muscle Weakness (1967); Nerve Damage (1979); Device Overstimulation of Tissue (1991); Pain (1994); Paralysis (1997); Loss of Range of Motion (2032); Inadequate Pain Relief (2388); Neck Pain (2433); Quadriplegia (2449); Shaking/Tremors (2515); Ambulation Difficulties (2544); Convulsion/Seizure (4406); Unspecified Nervous System Problem (4426); Increased Sensitivity (4538); Skin Inflammation/ Irritation (4545); Swelling/ Edema (4577); Insufficient Information (4580)
Event Date 08/17/2018
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 who was implanted with an implantable neurostimulator (ins) for spinal pain. It was reported that prior to the implant, the patient walked 10-13 miles per week, but post implant, the patient had trouble walking and was looking at getting a wheelchair. The patient had neck and head pain immediately after ins implant. The patient went into "convulsions" after lidocaine injections and would go into convulsions every times a person touched neck area; patient mentioned any time someone touched area around ins, the patient cried and wanted to throw up. The ins was supposed to address pain in arms, but ins did not address pain in patient's arms. After implant date. Patient's legs "gave out" and patient could no longer effectively walk. The patient also developed grand mal seizures and would have seizures up to 5 times per week(sometimes 3 seizures in one day); one of the grand mal seizures paralyzed patient. The patient said they "can never get off medication. " the patient said all the people they talked to in the medical field assumed the seizures were "pseudo-seizures" but patient did not think the seizures were "pseudo-seizures. " after the ins was turned off, the patient said the seizures were milder. The healthcare provider (hcp) said mild seizures were due to electrical signals still being emitted by the ins to the brain. The patient mentioned that their hcp had agreed to explant the ins as early as (b)(6) 2021. The patient was trying to determine if the implant procedure had been done incorrectly or if the ins had faults. Patient services specialist emailed patient advocate about the issue and requested patient call back. Additional information was received from the manufacturer representative (rep). It was reported that rep was not made aware of the seizures or the paralyzing event. Her explant is (b)(6) 2021.

 
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Brand NameINTELLIS
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
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 Key12347339
MDR Text Key267424208
Report Number3004209178-2021-12695
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 09/16/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/20/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/14/2019
Device MODEL Number97715
Device Catalogue Number97715
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/31/2021
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/14/2021
Was Device Evaluated By Manufacturer? No
Date Device Manufactured07/14/2018
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: 08/20/2021 Patient Sequence Number: 1
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