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U.S. Department of Health and Human Services

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

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MEDTRONIC PUERTO RICO OPERATIONS CO. SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number 97713
Device Problems Migration or Expulsion of Device (1395); Pocket Stimulation (1463)
Patient Problems Undesired Nerve Stimulation (1980); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271); Discomfort (2330); Injury (2348)
Event Type  malfunction  
Manufacturer Narrative
Other relevant device(s) are: product id: neu_unknown_lead. If information is provided in the future, a supplemental report will be issued.
 
Event Description
The manufacturing representative reported that the patient had an injury to the implantable neurostimulator (ins) site. After the injury the patient had to turn amplitude up to achieve therapy. The patient had lost therapy at the time of report. The healthcare professional (hcp) checked impedances and they were between 800-1100 ohms. The hcp turned up amplitude and the patient reported feeling stimulation again but the patient also reported sensation at the ins pocket site when contact 15 was used. Symptoms included a sensation at the ins pocket site. Additional information was received from the hcp via a manufacturer representative. It was reported that they made sure the affected contact, #15, was not used in programming. The patient was sent for x-ray, and there was no obvious fractures seen. The left lead moved down three contacts. The patient was sent home. A follow-up phone call revealed that the patient was getting stimulation in needed areas, but they still had to turn amplitude up a lot. Discomfort at the ins site would come and go. The physician was considering revision, but the patient was not ready for repeat surgery at this point. The patient was to call the hcp if stimulation became erratic or intolerable pain at the ins site. It was noted that a possible cause was the ins site having been accidentally hit by a door knob as a door was slammed into the patient from behind and the door knob hit the ins site. There were no issues right away, they started approximately two months later.
 
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Brand NameSURESCAN
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 Key8047798
MDR Text Key128250385
Report Number3004209178-2018-24912
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
P840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 11/07/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/07/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/28/2016
Device Model Number97713
Device Catalogue Number97713
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/17/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured08/06/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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