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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

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MEDTRONIC PUERTO RICO OPERATIONS CO. RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number 37714
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Wound Dehiscence (1154); Erythema (1840); Unspecified Infection (1930); Swelling (2091); Ulceration (2116); Injury (2348)
Event Date 06/18/2019
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: 3778-75, serial# (b)(4), implanted: (b)(6) 2019, product type: lead. If information is provided in the future, a supplemental report will be issued.
 
Event Description
The neuropathic pain patient reported through a manufacturer representative that a wound occurred at their implantable neurostimulator (ins) site. It was further reported the patient experienced ¿swelling and rupture at the edge of the pouch where the stimulator was implanted,¿ with a serious redness and ulceration problem near the wound. In regards to whether any external factors may have led or contributed to the issue, it was noted that ¿there may be improper postoperative care¿ and that ¿the specific reasons need to be diagnosed. ¿ the patient returned to their implant hospital and was admitted to review the issue with their physician. Examination of the patient found their ¿blood routing and the body temperature was normal. ¿ the wound was disinfected at that time, with no further interventions or actions planned. Further examinations and a surgical consultation were planned for the day after initial report, as the patient had arrived at the hospital at night. The issue remained unresolved at the time of report. No further complications were reported or anticipated. The patient's previous medical history included lymphoma and syringomyelia.
 
Manufacturer Narrative
Concomitant medical products: product id: 3778-75, serial#: (b)(6), implanted: (b)(6) 2019, product type: lead. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received reported the device was explanted. No further event information was reported; no further complications were reported or anticipated.
 
Manufacturer Narrative
(b)(4). The returned device (serial # (b)(4)) was subjected to a series of standard tests that include but is not limited to visual inspection, output and telemetry testing, and functional testing. The implantable neurostimulator (ins) passed functional testing. If information is provided in the future, a supplemental report will be issued.
 
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Brand NameRESTORE SENSOR
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
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key8717614
MDR Text Key148634922
Report Number3004209178-2019-12013
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeCH
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
Report Date 04/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/20/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/28/2019
Device Model Number37714
Device Catalogue Number37714
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/04/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/24/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/12/2018
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: 06/20/2019 Patient Sequence Number: 1
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