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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

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MEDTRONIC MED REL MEDTRONIC PUERTO RICO RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number 37712
Device Problems High impedance (1291); Low Battery (2584); Device Displays Incorrect Message (2591)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/31/2018
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare professional (hcp), via a manufacturer representative (rep), regarding a patient with an implantable neurostimulator (ins) for failed back surgery syndrome. It was reported that the patient came in reporting end of service (eos). The rep interrogated the ins battery and noticed that impedances on 9,11 ,12,13,14,15 were all over 10,000. The rep said they were unaware of anything that would have led to the leads being out. The patient was getting on the surgery schedule for a replacement. It was noted that the issue was resolved at the time of the report and surgical intervention was planned. No symptoms were reported. No further complications were reported/anticipated.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information received from the manufacturing representative (rep) indicated that there were high impedances found in the leads in the patient¿s lumbar region. They stated that the patient reports good pain relief. The patient¿s implantable neurostimulator (ins) is at end of service (eos) and the patient will be sent to full system revision due to the impedance issue. No further complications were reported or anticipated.
 
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Brand NameRESTORE ULTRA
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
Manufacturer (Section D)
MEDTRONIC MED REL MEDTRONIC PUERTO RICO
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer (Section G)
MEDTRONIC MED REL MEDTRONIC PUERTO RICO
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 Key7573664
MDR Text Key110235271
Report Number3004209178-2018-12721
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeUS
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
Report Date 06/15/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/06/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/14/2010
Device Model Number37712
Device Catalogue Number37712
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 Received06/12/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured02/19/2009
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: 06/06/2018 Patient Sequence Number: 1
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