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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 Intermittent Continuity (1121); Disconnection (1171); Failure to Deliver Energy (1211); High impedance (1291); Therapy Delivered to Incorrect Body Area (1508); Battery Problem (2885); Therapeutic or Diagnostic Output Failure (3023); Insufficient Information (3190)
Patient Problems Unspecified Infection (1930); Undesired Nerve Stimulation (1980); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271)
Event Date 01/08/2020
Event Type  Injury  
Manufacturer Narrative

Concomitant medical products: product id: 39565-30, serial#: (b)(4), implanted: (b)(6) 2010, product type: lead. Other relevant device(s) are: product id: 39565-30, serial/lot #: (b)(4), ubd: 27-may-2014, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.

 
Event Description

Information was received from a patient regarding their implantable neurostimulator (ins). It was reported that ever since the implant, he has not had reliable therapeutic benefit. Patient has 15 electrodes on his leads and only 5 work. Patient is not getting the stimulation that he was getting before. It seemed like it was working good but then wouldn't cover right side of his back. Patient would go for reprogramming and get it a little better but then the legs would quit working. Patient would get a sharp stimulation sensation in his left side of ribs so then he would go again for reprogramming and got rid of that. The reps were never really able to get the stimulation settings to where he needs them and he would like to meet with someone again to discuss this. Now he is having a problem where when he breaths in he loses stimulation sensation on the left side and when he exhales the sensation comes back. So he thinks he has a broken lead. Patient was redirected to their hcp. No further complications were reported. Additional information was received from the consumer via manufacturer's representative. It was reported that the patient experienced a loss of paresthesia from tonic scs stimulation even though the ipg was functional and charged. Patient was getting oor on patient controller. No known contributing factors. Patient will have imaging and other studies performed. Patient to follow-up with surgeon to investigate possible surgical intervention if imaging shows damage to leads or extensions. Issue not resolved at this time. Intervention planned. No further complications were reported/anticipated. Additional information was received from the rep. It was reported that the rep saw the patient for his post-op appointment on (b)(6) 2020. According to the notes, high impedances were observed in the or and in the recovery room at the time of battery replacement. The cause was unknown. To rep's knowledge, it has not been confirmed if the lead was broken. On (b)(6) 2020, at the post-op appointment, rep reprogrammed around the bad contacts to provide better stimulation coverage. It was unknown what actions/interventions took place, if the issue was resolved. Rep believed that the hcp was aware. No further complications were reported.

 
Manufacturer Narrative

Product id: 39565-30, serial# (b)(4), implanted: (b)(6) 2010, product type: lead; product id: 3708140, serial# (b)(4), implanted: (b)(6) 2010, explanted: (b)(6) 2020, product type: extension; product id: 3708140, serial# (b)(4), implanted: (b)(6) 2010, explanted: (b)(6) 2020, product type: extension. If information is provided in the future, a supplemental report will be issued.

 
Event Description

Additional information was received from the rep. It was reported that at the patient appointment on (b)(6), the patient still had 5 electrodes with bad impedances. Rep was able to program around those to get the patient the appropriate coverage. The patient said the coverage was still not as good as he had before the january battery replacement. It was unknown why the extension came out of the header block. The 40 cm extensions were not saved or returned to manufacturer as the hcp did not believe they caused the malfunction. Hcp just thought the 60 cm extensions would provide a little more slack. After replacing the extensions, since we still have bad impedances, he is convinced the problem must be in the lead. However, he did not want to replace the lead at this time. He wants to see if the patient is getting satisfactory coverage before doing anything else. 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 Key10010909
MDR Text Key189481843
Report Number3004209178-2020-07873
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 06/19/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/29/2020
Is This An Adverse Event Report? Yes
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 Received06/18/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured12/08/2019
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: 04/29/2020 Patient Sequence Number: 1
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