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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

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MEDTRONIC PUERTO RICO OPERATIONS CO. RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number 37714
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Nerve Damage (1979); Pain (1994); Therapeutic Effects, Unexpected (2099); Distress (2329)
Event Date 01/20/2015
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Concomitant medical products: product id 3778-60, serial# (b)(4), implanted: (b)(6) 2015, product type: lead. Product id 3778-60, serial# (b)(4), implanted: (b)(6) 2015, product type: lead. 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 patient reported that the one lead trial worked perfect but stated that the health care professional (hcp) put in a second lead implant. The second lead laid across the spine too long and damaged a nerve. They removed the lead but since then, they had upper left back pain, shoulder pain that was not covered by the stim therapy. The implant took care of the original pain. The patient was to follow-up with their health care professional (hcp) to resolve their symptoms. It was noted that the hcp had said that they could not put another wire too dangerous and all they could do was wait for science to come out with a new therapy. Other relevant medical history includes spinal pain.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Additional information was received from the consumer on 04-aug-2016 regarding whether the managing healthcare professional was made aware of the patient¿s pain in the upper left back and shoulder; the patient reported that the last appointment with the healthcare professional was in (b)(6) 2016. There were no reported steps taken to resolve the patient¿s pain in the upper left back and shoulder. The patient was told the second lead wire inserted during the initial implant was lying across the patient¿s spine, and it was eventually removed. It was noted that the patient was unaware a second lead had been inserted until she had recovered from the anesthetic. After the second lead was removed, the patient¿s original pain was gone but a second pain had developed elsewhere. The pain issue was not resolved and the patient was unhappy. Nothing could be done about the second pain because lead replacement was too dangerous at this time.
 
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Brand NameRESTORE SENSOR
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
diane wolf
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263987
MDR Report Key5800067
MDR Text Key100702887
Report Number3004209178-2016-14370
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
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 08/24/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/16/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/28/2015
Device Model Number37714
Device Catalogue Number37714
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 Received08/04/2016
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/02/2014
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: 07/16/2016 Patient Sequence Number: 1
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