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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 Battery Problem (2885); Insufficient Information (3190); Appropriate Term/Code Not Available (3191)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/09/2015
Event Type  Injury  
Manufacturer Narrative
Other relevant device(s) are: product id: 977a260, serial/lot #: (b)(4), ubd: 24-aug-2019, udi#: (b)(4); product id: 977a260, serial/lot #: (b)(4), ubd: 27-jun-2019, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a patient who was implanted with a neurostimulator for spinal pain. It was reported that the therapy never worked for the patient and she did not get therapeutic benefit because one of the leads were not working. The patient planned to have the device removed and they were redirected to their healthcare professional (hcp) to discuss the symptoms. There were no further complications reported or anticipated.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the patient on (b)(6) 2018. The patient indicated that there was not a change in activity that led to the leads and therapy not working. The issue has not been resolved. They have never had coverage in their back since it was put in. No further complications were reported/are anticipated.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare provider (hcp) regarding the patient. The hcp reported that the patient is scheduled for an mri of their knee, unrelated to their device or therapy. They stated that the patient¿s device has not been working for a long time and is dead. No further complications were reported or anticipated.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Section 'device' information references the main component of the system and other applicable components are: product id: 977a260, serial# (b)(4), implanted: (b)(6) 2015, explanted: (b)(6) 2019, product type: lead; product id: 977a260, serial# (b)(4), implanted: (b)(6) 2015, explanted: (b)(6) 2019, 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 on 2019-may-23. It was reported that the patient was having problems with their implantable neurostimulator (ins) and half of the leads weren't working. The system was removed on (b)(6) 2019, and the patient was interested in the return analysis. There were no further complications reported or anticipated.
 
Manufacturer Narrative
Product id: 977a260, serial# (b)(4), implanted: (b)(6) 2015, explanted: (b)(6) 2019, product type: lead; product id: 977a260, serial# (b)(4), implanted: (b)(6) 2015, explanted: (b)(6) 2019, product type: lead. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the consumer 2019-05-28. The patient verified that all of her device were removed because they were not working anymore. No further complications were reported/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 Key7756504
MDR Text Key116897517
Report Number3004209178-2018-17518
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 consumer,health professional
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 05/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/07/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/14/2016
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 Received05/28/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/22/2015
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: 08/07/2018 Patient Sequence Number: 1
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