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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 Therapy Delivered to Incorrect Body Area (1508); Inappropriate/Inadequate Shock/Stimulation (1574); Impedance Problem (2950)
Patient Problems Undesired Nerve Stimulation (1980); Therapeutic Effects, Unexpected (2099); Malaise (2359); Electric Shock (2554)
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare professional via manufacturer representative regarding a patient who was implanted with an implantable neurostimulator (ins) for spinal pain. It was reported that patient was experiencing zapping and shocking through whole body when stimulation was off. Patient normally felt stim in their waist and legs. Patient was feeling shocking under arms, in joints and through the whole body. The continuous shocking started 5 days prior to the date of report. There were a couple instances prior to that as well. The first was 2-3 months prior to the date of report. That's when patient called 911 because they thought they were having a heart attack. Patient claimed that they changed their medication couple of days prior to the date of report. Patient's stim was off. The programmer diary showed that over the past five days, the ins was off the majority of the time. The stim was on 5-20 % each day. Patient confirmed that they had stim off but had turned it on when they were not feeling well. A program was turned on and the patient felt flutter or zap in knee at 2. 5 v and the electrodes used were +3 -4 +5. Other programs were tried which resulted in fluttering in the crotch area and stim in stomach. Impedance measurements were taken. At 0. 7 v the impedances were between 699-971 ohms except 12 was at 2091 ohms.
 
Manufacturer Narrative
Upon further review of the information, device code (b)(4) is not applicable. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
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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 clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key6277666
MDR Text Key103283860
Report Number3004209178-2017-01726
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
PMA/PMN Number
P840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/25/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/25/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/28/2017
Device Model Number97713
Device Catalogue Number97713
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/25/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured01/07/2016
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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