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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 Failure to Interrogate (1332); Energy Output Problem (1431); Charging Problem (2892); Communication or Transmission Problem (2896)
Patient Problems Device Overstimulation of Tissue (1991); Pain (1994); Inadequate Pain Relief (2388); Insufficient Information (4580)
Event Type  Injury  
Event Description
Information was received from a patient (pt) via manufacturer representative (rep) who was implanted with an implantable neurostimulator (ins). It was reported that it feels like wires are trying to come out of patient's back. She is having nerve pain with stimulation on and if she turns it up then her body goes to jumping and she knows she's not supposed to feel it at all. Has switched settings and still not getting relief at all. Patient's hurting so badly she can¿t even function. Additional information was received from the rep. The rep reported that the cause of the lead and therapy issues wasn't determined. The rep reprogrammed the patient. There were no further complaints. Additional information was received. It was reported the patient was seen for a spinal cord stimulation (scs) interrogation on (b)(6) 2021. They had trouble communicating and maintaining charging sessions. Per logs charging coupling was excellent and took 1. 5-2. 2 hours to charge when battery was at 10%. The patient has had multiple pieces replaced except remote battery. The manufacturer representative attempted to recharge and came across the same issue, unable to find device. They grabbed a 97745fa and used the patient's battery and recharger. The ins was at 80%. Charging to 100% took 15 minutes and maintained excellent coupling. The patient was charging every 23 hours on average with current settings, which was close to energy check at 1. 2 days. The patient was educated on inserting cord into remote as to not bend copper teeth. In the past the patient had been inserting from an angle. It was noted the patient had an appointment next month to interrogate scs. Additional information was received. It was reported the patient had issues charging again.
 
Manufacturer Narrative
Concomitant medical products: product id: 977a260, serial# (b)(4), implanted: (b)(6) 2020, product type: lead. Product id: 977a260, serial# (b)(4), implanted: (b)(6) 2020, product type: lead. 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
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
glen belmer
7000 central avenue ne rcw215
minneapolis, MN 55432
6122713209
MDR Report Key12856467
MDR Text Key285621198
Report Number3004209178-2021-17445
Device Sequence Number1
Product Code LGW
UDI-Device Identifier00643169781702
UDI-Public00643169781702
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup,Followup
Report Date 09/19/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/22/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/28/2021
Device Model Number97715
Device Catalogue Number97715
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Manufacturer Received08/25/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured02/10/2020
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: 11/22/2021 Patient Sequence Number: 1
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