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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

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MEDTRONIC PUERTO RICO OPERATIONS CO. SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR Back to Search Results
Model Number 97714
Device Problems Malposition of Device (2616); Patient Device Interaction Problem (4001)
Patient Problems Undesired Nerve Stimulation (1980); Pain (1994); Ambulation Difficulties (2544)
Event Date 04/14/2020
Event Type  malfunction  
Event Description
Information was received from a patient who was implanted with an implantable neurostimulator (ins) for spinal pain. The reason for call was the patient (pt) mentioned that "they think they need to have a doctor take it out and put it somewhere else because its affecting them when they lean backwards, its painful at the belt line, like its hitting a nerve in there and they cant stand up straight". The pt stated that they had "a major back surgery a year and a half ago, and they thought it started doing this when they were doing physical therapy". The patient was redirected to their healthcare provider to further address the issue. Pt stated that they would be following up with healthcare provider (hcp) on october 27th.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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Brand NameSURESCAN
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
Manufacturer (Section D)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
MDR Report Key12724595
MDR Text Key281998675
Report Number3004209178-2021-16163
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
PMA/PMN Number
P840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial
Report Date 10/29/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/29/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/14/2016
Device Model Number97714
Device Catalogue Number97714
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/13/2021
Is This a Reprocessed and Reused Single-Use Device? No

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