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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 97702
Device Problems Premature Discharge of Battery (1057); Battery Problem (2885); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hypersensitivity/Allergic reaction (1907); Complaint, Ill-Defined (2331); Injury (2348); Test Result (2695)
Event Date 10/12/2016
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a patient implanted with an implantable neurostimulator (ins). It was reported that the patient had some kind of allergic reaction on the skin. The hospital was asking if there was any form of black rubber or p-phenylenediamine (ppd) in the ins or lead, not necessarily touching skin but inside somewhere. It was noted that they also mentioned paraphenylenediamine in finish. Additional information was received from the manufacturer representative reporting that the cause of the allergic reaction was not determined. No further complications were anticipated.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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
A health care provider (hcp) reported via the company representative (rep) that the implantable neurostimulator (ins) battery depleted rapidly in seven months. Troubleshooting and diagnostics were performed: programming, impedance measurements, and x-rays. There was unknown rush in the ins pocket and wound area. There was also leucocytes (no bacteria) in the ins pocket. The action taken to resolve the issue was the ins was explanted, and will be replaced in the future. The patient was alive with injury.
 
Manufacturer Narrative
Concomitant medical products: product id: 3550-29, lot# unknown, product type accessory. Analysis results were not available at the time of this report. A follow-up report will be sent when analysis is completed.
 
Manufacturer Narrative
(b)(4).
 
Manufacturer Narrative
Device analysis for ins (b)(4) revealed no significant anomaly. The ins battery reached normal end of life. Telemetry and output was okay. The ins was received with group c active and the battery status at eos. The eos bit was reset in order bench test and functionally test the ins. The ins had three groups programmed. Three longevity estimates were done based on the programmed parameters from the initial review of the ins when it was received for analysis. The longevity estimates range from 0 months to 4. 26 months to eri, and 2. 97 months to 7. 26 months to eos. According to the trace report, eri occurred at 6. 54 months ((b)(6) 2016) and eos occurred at 7. 73 months ((b)(6) 2016). Based on the parameters received the ins experienced normal battery depletion.
 
Event Description
The rep additionally reported that in regards to ins programming they looked for the best response with the settings, therefore the ins had program a and program b. Program a settings were: 01234567 --+++ 330 us, 80 hz. Program b settings were: 01234567 -+-++ 390 us, 75 hz and program c 2x 130 hz. Impedance measurements were normal, exact values were not known. The cause of the rush in the battery pocket/wound area and leukocytes was not known, there was no bacteria. The patient outcome was good, rush disappeared after removing the battery.
 
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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 Key6218139
MDR Text Key102325476
Report Number3004209178-2017-00028
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeFI
PMA/PMN Number
P840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 10/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/03/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/28/2017
Device Model Number97702
Device Catalogue Number97702
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/02/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/08/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/07/2016
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: 01/03/2017 Patient Sequence Number: 1
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