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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 97714
Device Problems High impedance (1291); Improper or Incorrect Procedure or Method (2017); Low Battery (2584); Charging Problem (2892)
Patient Problems Pain (1994); Therapeutic Response, Decreased (2271)
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a consumer via a manufacturer representative (rep) regarding a patient with an implantable neurostimulator (ins). It was reported that the patient was unable to charge the ins. The rep saw the patient on (b)(6) at the healthcare provider (hcp office). The ins was determined to be overdischarged. The patient said he was pain free for about 4 months and didn¿t charge the ins. Then, when the patient¿s pain came back he couldn¿t charge. It was explained to the patient that he needed to charge at least monthly even if the device is not being used. The patient said he forgot to charge. The ins was trickle charged in the office and the patient came back once the ins was charged. A device reset was done, and impedance check revealed impedances over 10,000 on contacts 8, and 10-12. All other contacts were within normal limits. The device was reprogrammed, and the patient was happy with the coverage in the low back and left leg. The issue was reported to be resolved. No further complications were reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a manufacturer representative (rep). It was reported that the cause of the high impedances was not determined.
 
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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 Key7578037
MDR Text Key110355289
Report Number3004209178-2018-12831
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,consum
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/12/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/07/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/14/2017
Device Model Number97714
Device Catalogue Number97714
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 Received06/07/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured12/20/2016
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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