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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 97702
Device Problems Intermittent Continuity (1121); Failure to Deliver Energy (1211); Unintended Collision (1429); Inappropriate/Inadequate Shock/Stimulation (1574); Low impedance (2285)
Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099); Burning Sensation (2146); Injury (2348); Electric Shock (2554)
Event Date 07/29/2018
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information received from the consumer via the manufacturer representative (rep) reported intermittent stimulation after an accident. The patient was involved in a car accident whereby a car entered from behind and they were injured in the lower back. Since then, they report that whilst there seems to be no problem with the patient programmer itself. Stimulation sometimes disappears when they move. It reappeared on its own within an hour or more. Patient reports since accident, pain around the implantable neurostimulator (ins) area, whether stimulation was on or off. The type of pain was burning and expansion. Factors that may have led or contributed to the issue was a car accident. The clinician programmer said battery was okay, impedance was low apart from contact 2 which was not in use anyway. No interventions were taken to resolve the issue. The issue was not resolved. No surgical intervention occurred or was planned. Patient reported that they had a ct scan made including the ins area on day of accident and the physician observed no change. No change was observed on any change on the skin. No further complications were reported/anticipated.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received from manufacturing representative reported that there was shocking and pain sensation after the car accident.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received that there was no actions/interventions but appears to be due to damage to implantable neurostimulator (ins) and the physician said that they would see the patient to determine next step. The cause of the low impedance was not determined and the intermittent stimulation after a car accident had not been resolved. No further complications were reported/anticipated.
 
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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 Key8047726
MDR Text Key128251680
Report Number3004209178-2018-24910
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,consum
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 12/26/2018
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 Date08/28/2017
Device Model Number97702
Device Catalogue Number97702
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 Received12/01/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/12/2016
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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