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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 Low Battery (2584); Device Displays Incorrect Message (2591); Battery Problem (2885); Insufficient Information (3190)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/28/2018
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 patient with an implantable neurostimulator (ins) for multiple back operations. The patient indicate d that maybe a week ago there was an elective replacement indicator (eri) on their ins. They looked up the eri code and saw that it meant that the ins is going out. Patient services reviewed eri considerations. There was an allegation against the ins longevity. The patient was not sure if they want to get another non-rechargeable device if the ins will only last 2 years. The patient inquired if their next device will only last 2 years like their current device. The patient relies on their device and is not sure they can rely on another device moving forward. The patient was redirected to follow up with their healthcare professional (hcp) to discuss their options. There were no patient symptoms reported and no complications reported.
 
Manufacturer Narrative
Product id 3998, lot# j0443868v, implanted: (b)(6) 2004. Product type lead. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the patient. They stated that they had the device explanted on (b)(6) 2018 because it was not working and they had a few problems with the unit. They stated at the office in july, the machine was showing a warning and a manufacturer representative (rep) had stated the ins was going out and the leads had gone out; only 4 of the 16 contacts were working. No further patient complications were reported as a result of this event. A rep was contacted who stated they were not aware of this event. No further patient complications were reported asa result of this event.
 
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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 Key7575271
MDR Text Key110340636
Report Number3004209178-2018-12779
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 09/14/2018
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? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/28/2017
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 Received08/22/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured12/30/2015
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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