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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 Problem Overheating of Device (1437)
Patient Problems Wound Dehiscence (1154); Burn(s) (1757); Erythema (1840); Burning Sensation (2146); Skin Inflammation/ Irritation (4545)
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 manufacturer representative regarding a patient who was implanted with an implantable neurostimulator (ins) for unknown indications for use. It was reported that pt has developed irritation and redness at ins pocket site with ins recharging. Pt also feeling heating as well with recharging. Caller first discussed this with pt about 2 weeks ago but pt didn't have any symptoms at pocket site and caller doesn't know exactly when pt started having a concern about this issue. Pt seen again last friday then pt had developed symptoms of irritation and redness at pocket. When asked, caller didn't know how pt is charging (e. G. Laying down, leaning up against recharger, etc), duration of recharge sessions, if pt is charging more often than usual do to increased stimulation use or programming change, or if rtm itself is getting warm. Caller says that managing hcp sent cultures on the pocket and they came back negative. Caller doesn't know exactly when this was done. Caller doesn't know if pt using recharge belt but pt does charge thru a t-shirt. Technical services reviewed checking for any changes in pt's recharging habits or frequency or duration, lowering charging speed, charging for shorter durations to see if this helps the issue. (b)(6) 2021 (rep): the rep reported that after conference call rep called provider and spoke to her about possibilities of charger needing to be replaced. Rep will recommend that patient call patient services you get new one sent out. Provider will follow up to see if redness gets better with new charger. (b)(6) 2021 (b)(4)/update: additional information from the rep indicated that a green suture became visible out of ins pocket so they did a revision procedure yesterday and replaced ins. There was some question about pt's body rejecting the sutures but it's currently unclear what the root cause is for the irritation at the pocket site is.
 
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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 Key11624290
MDR Text Key259344091
Report Number3004209178-2021-05552
Device Sequence Number1
Product Code LGW
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 company representative,consum
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 09/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/06/2021
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 Returned to Manufacturer04/15/2021
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/09/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/29/2020
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: 04/06/2021 Patient Sequence Number: 1
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