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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, IMPLANTED (PAIN RELIEF)

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MEDTRONIC PUERTO RICO OPERATIONS CO. SURESCAN STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) Back to Search Results
Model Number 97714
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Nerve Damage (1979); Ambulation Difficulties (2544)
Event Date 07/26/2016
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
The main component of the system and other applicable components are: product id: 97714, serial# (b)(4), implanted: (b)(6) 2016, product type: implantable neurostimulator. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
Event Description
The manufacturer's representative (rep) reported the consumer had a routine battery replacement due to normal battery end of life on (b)(6) 2016. Following this the implantable neurostimulator (ins) was working well and there were no issues (s/n (b)(4)). On (b)(6) 2016 the consumer had a stimulation trial to evaluate treatment in a new area. After a successful trial the consumer was implanted on (b)(6) 2016. A couple of days after this the consumer had lack of function in their right leg (this was the system that resulted in the leg weakness for the consumer). On (b)(6) 2016 the consumer had an mri performed at their post-operative visit where no significant findings were shown to determine why the consumer was having these issues. The physician did a physician examination of the consumer where they could stand up on both feet, but needed assistance to walk. On (b)(6) 2016 the rep. Reported the consumer had return of function to their leg, but the physician explanted this system "prophylactically" because they wanted to watch things. It was noted an mri was performed which didn't show any apparent reason for the leg weakness. Following this the consumer recovered nicely. Relevant medical history includes non-malignant pain, complex regional pain syndrome type i, and spinal pain.
 
Event Description
Additional information received from the consumer reported that she had physical therapy since (b)(6) because of the implant. The patient stated it did nerve damage and she was still in physical therapy. No further complications were anticipated.
 
Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a manufacturer's representative (rep). It was reported that the patient will be meeting with the rep on (b)(6) to check recharging stats. It was also discussed on calling technical services to assist with recharging issues if needed. No symptoms were reported. No further complications were reported.
 
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Brand NameSURESCAN
Type of DeviceSTIMULATOR, SPINAL-CORD, IMPLANTED (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 Key5947060
MDR Text Key101880439
Report Number3004209178-2016-18810
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
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 06/14/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/13/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/28/2017
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 Received05/23/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/06/2016
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: 09/13/2016 Patient Sequence Number: 1
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