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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

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MEDTRONIC NEUROMODULATION SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number 97713
Device Problems Break (1069); Intermittent Continuity (1121); Failure to Deliver Energy (1211); Malposition of Device (2616); Battery Problem (2885); Protective Measures Problem (3015); Insufficient Information (3190)
Patient Problems Seroma (2069); Discomfort (2330); Impaired Healing (2378); Fluid Discharge (2686); Patient Problem/Medical Problem (2688)
Event Date 06/01/2018
Event Type  Injury  
Manufacturer Narrative
Information references the main component of the system and other applicable components are : product id: neu_unknown_lead, lot# unknown, product type: lead. Information references the main component of the system. Other relevant device(s) are: product id: neu_unknown_lead, serial/lot #: unknown, ubd: , udi#:. If information is provided in the future, a supplemental report will be issued.
 
Event Description
The healthcare professional reported repeated unintended switch off events. There were no external factors known. No diagnostics or troubleshooting was performed. No interventions/actions were taken. It was unknown if the issue was resolved at the time of report. The patient stated that the device sometimes was stopping it work without making anything. The patient has had a lot of revision in the past two years, including changing the leads or the place of the leads, connecting to the implantable neurostimulator (ins). The revisions were sore. The device data showed that the was a parity power on reset (x400) on (b)(6) 2018. Apart from that there was no abnormalities visible, no overdischarges, and no therapy loss with stimulation on. There have been up to four revisions without changing the system. Two time for changing the leads. The last lead changing had been in february. The surgeon tried to replace the lead and it was damaged.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the manufacturer representative (rep). It was reported that the revision was because of the placement of the lead and during this surgery it had been damaged. There had been no problem with the lead before.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the manufacturer representative (rep). It was reported that the revision was because of the placement of the lead and during this surgery it had been damaged. There had been no problem with the lead before. (b)(4) 2018 (rep, for): additional information was received from the rep. It was reported that the revisions had not been reported to the manufacturer because the they were not problems with the system. They had been problems with the healing, and wound fluid/seromas. There had only been one replacement after trying to change the placement of the surgical lead. It was damaged while uncovering it.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Note that section d information references the main component of the system and other applicable components are: product id: 977c190, lot#: va18r3u013, implanted: (b)(6) 2017, explanted: (b)(6) 2018, product type: lead. Additional information clarified that there was only one lead that was revised, not two as previously reported. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the rep. It was noted that the first implant was done with a 5-6-5 configuration surgical lead on (b)(6) 2017. The replacement was done on (b)(6) 2018 with another of the same model lead which is still implanted as of (b)(6)2018.
 
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Brand NameSURESCAN
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
Manufacturer (Section D)
MEDTRONIC NEUROMODULATION
800 53rd ave ne
minneapolis MN 55421 1200
Manufacturer (Section G)
MEDTRONIC NEUROMODULATION
800 53rd ave ne
minneapolis MN 55421 1200
Manufacturer Contact
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key7704207
MDR Text Key114538830
Report Number3007566237-2018-02158
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeGM
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,Followup,Followup,Followup,Followup
Report Date 10/03/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/19/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
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 Received08/08/2018
Was Device Evaluated by Manufacturer? No Answer Provided
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: 07/19/2018 Patient Sequence Number: 1
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