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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 97702
Device Problems Migration or Expulsion of Device (1395); Overheating of Device (1437)
Patient Problems Pain (1994); Burning Sensation (2146); Skin Inflammation (2443)
Event Date 04/12/2018
Event Type  malfunction  
Manufacturer Narrative
Information references the main component of the system. Other relevant device(s) are: product id: 977a260, serial/lot #: (b)(4), udi#: (b)(4); product id: 977a260, serial/lot #: (b)(4), udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a consumer via a manufacture representative regarding a patient implanted with an implantable neurostimulator (ins). It was reported that the patient had a blister and was feeling a burning sensation around the battery site following an appointment on (b)(6) 2018 in which the amplitude was increased from 1 to 2 ma. It was also noted that the patient programmer was not communicating with the ins but this resolved after the rep replaced the batteries. Additional information received from the rep reported that the patient developed a 'burn' after programming on the left side of their mid-thoracic area about 2. 5 in length. The patient showed a picture of a dark pencil eraser sized lesion from (b)(6). This issue was all healed at the time of the call with no residual skin sensitivity. The patient's hcp initially thought this skin issue was shingles, but the patient did not believe so. It was also reported that the x-ray showed that the leads had migrated. The patient denied any falls but stated that they had pneumonia in (b)(6) and coughed for 3 straight weeks. The x-rays showed that the leads retracted to the t-9 vertebrae. New electrode configurations were programmed to attempt to improved pain control. Follow-up was conducted. No further complications were reported.
 
Manufacturer Narrative
Information references the main component of the system and other applicable components are: product id (b)(4) lot# serial# (b)(4) implanted: explanted: product type lead product id (b)(4) lot# serial# (b)(4) implanted: explanted: product type lead. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received from the representative. It was reported that the cause of the burning sensation at the battery site, blistering and lesion was not determined. After further evaluation of the patient the physician didn't think it was device related. Some new programming was performed to resolve the issues and the pw was reduced to 450 and the rate was reduced to 60 to help resolve the lead migration issue. The patient reported that the stimulation coverage felt better. This information was confirmed with the physician/account. No further complications reported.
 
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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 Key7432921
MDR Text Key105764858
Report Number3004209178-2018-08108
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,consum
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/09/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/16/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/14/2018
Device Model Number97702
Device Catalogue Number97702
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 Received04/20/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/19/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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