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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 Disconnection (1171); Malposition of Device (2616); Battery Problem (2885); Charging Problem (2892); Material Deformation (2976); Appropriate Term/Code Not Available (3191)
Patient Problems Therapeutic Effects, Unexpected (2099); No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Event Date 05/01/2018
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: 977c265, (b)(4), implanted: (b)(6) 2017, explanted: (b)(6) 2018, product type: lead. Other relevant device(s) are: product id: 977c265, serial/lot #: (b)(4), (b)(6), (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a consumer via a manufacturer's representative (rep) regarding an implantable neurostimulator (ins). It was reported that the patient was not receiving any stimulation benefits from the old system. The lead was placed too far left. The patient had difficulty recharging. It was noted that the battery was discharged at the time of surgery. It was mentioned by the surgeon that there may have been a high impedance problem with the old system, but were unable to determine the high impedances at the time of the surgery. The lead was replaced. An impedance check was run with the old leads connected to the new battery and the level was normal. The lead was replaced to be safe. No further complications were reported or anticipated.
 
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 a consumer regarding the patient who was implanted with a neurostimulator for spinal pain and failed back surgery syndrome. It was reported that the patient did not get any therapeutic relief from the previous system. The consumer reported that it was eventually discovered that ¿it was bent and not connected. ¿ this information is contradictory to the information received at the time of the replacement on (b)(6) 2018. There were no further complications reported or 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 Key7766959
MDR Text Key116538789
Report Number3004209178-2018-17691
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,Followup
Report Date 11/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/09/2018
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 Received11/15/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured12/27/2016
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: 08/09/2018 Patient Sequence Number: 1
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