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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Discomfort (2330); Weight Changes (2607)
Event Date 02/26/2015
Event Type  Injury  
Manufacturer Narrative

Concomitant products: product id: 977a260, serial#: (b)(4), implanted: (b)(6) 2015, product type: lead. Product id : 977a260, serial#: (b)(4), implanted: (b)(6) 2015, product type: lead. If information is provided in the future, a supplemental report will be issued.

 
Event Description

A health care provider (hcp) reported the patient was extremely thin and boney and the implantable neurostimulator (ins) and coiled leads under battery were bothering them anytime they lay on their back. The patient had pain at the ins site/ pocket. The patient discussed with the hcp moving the ins to another location as the patient wanted the ins removed completely. The patient¿s husband disagreed with the removal as the ins did relieve the patient¿s chronic pain. The patient¿s indication for use includes non-malignant pain and failed back surgery syndrome. The change in therapy/ symptoms was considered sudden. The patient reported that the entire spinal cord stimulation system was removed on (b)(6) 2015. The patient reported that following permanent implant of the spinal cord stimulation system, her weight went from (b)(6) to (b)(6) pounds. The implantable neurostimulator area was painful to the touch, and she could not apply any amount of pressure in the area. The patient could not take it, so she just had it all removed to resolve the issue.

 
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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
Manufacturer (Section G)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer Contact
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key12385706
MDR Text Key268729640
Report Number3004209178-2021-13088
Device Sequence Number1
Product Code LGW
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial
Report Date 08/30/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/30/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date12/14/2015
Device MODEL Number97714
Device Catalogue Number97714
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 Received08/24/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured01/19/2015
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: 08/30/2021 Patient Sequence Number: 1
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