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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 Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bacterial Infection (1735); High Blood Pressure/ Hypertension (1908); Unspecified Infection (1930); Pain (1994); Therapeutic Effects, Unexpected (2099); Malaise (2359); Disability (2371); Lethargy (2560); Weight Changes (2607); Test Result (2695)
Event Date 06/01/2016
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.
 
Event Description
Additional information was received from the patient reporting that they have had multiple spinal operations and vertebral fusions extending from t10 to s1, including their pelvis. As a result, i had a high degree of chronic back pain that was only partially responsive to narcotics and other pain relievers. Therefore, in (b)(6)2016, the patient stated they had their ins implanted which initially gave them some pain relief, but even with several modifications of the settings and other experiments failed to bring them relief. Consequently, they indicated that they never used it after august, but stated that it remained unused in their back until (b)(6)2016 (this date is unclear according to the patient and our records the patient did not have their device at this time). In october 2016, it was reported that the patient had additional medical problems including worsening of their back pain. It was reported that this included weight loss, lethargy, hypertension and a sense of being unwell. It was indicated that they did not have a fever nor did they have an increase in their white blood cell counts. As a part of many evaluations however, it was noted that their esr and crp were markedly elevated and since the patient noted that they were a retired chief professor of infectious diseases, they suspected that an indolent infection of something occurred related to their prior surgeries or to the implantation of their ins or power generator. A ct bone scan suggested that there was an infection near the insertion of the implant at t10. After consultations with several infectious disease and orthopedic specialists and because their ins was not being used, it was removed and they carefully cultured many parts of the device including the generator, several portions of the connecting cords and the electrodes that entered into the subdural space. All of these cultures obtained under sterile conditions grew proprionobacter acnes. As the patient and the other specialists involved were familiar, this indicated a long standing p. Acnes infection of the device probably from the time of placement in (b)(6)2016. As a result of the radiologic, laboratory and culture findings, the device was removed in march 2017 and the patient was treated with keflex 500mg qid for six months. Over the six-month period, which just ended, the esr and crp fell and became normal only after four months of antibiotic therapy. The patient¿s nonspecific symptoms had remitted somewhat, but they had many reasons for back pain and other symptomology. It was reported that the patient suspected that this low grade nosocomial infection was due to skin bacteria and contamination at the time of the device replacement and was not prevented with a dose of vancomycin. It was probably not commonly recognized, because no one bothered to evaluate for such problems. They reported that p. Acnes is a very common nosocomial infection with any catheter or any foreign body. They stated that they were sure that a significant proportion of patients with this device had such infections, but that they were not recognized nor were they presented with dramatic or fatal symptoms. The patient stated that they had other concerns about the device and the risk of infections that could compromise health of the patients. No further complications were reported/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 reporting that hospitalization, disability/permanent damage, and other serious (important medical event) were the outcomes of the event. No further complications were reported/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
Information was received from a consumer via a manufacturer representative regarding a patient who was implanted with a neurostimulator for non-malignant pain. It was reported to the manufacturer representative that the patient suspected that their device was infected and that they wanted it explanted. After the patient was implanted they had a fusion performed by a different physician on an unknown date. This was reported as a possibly associated environmental factor. There were no other significant events that occurred between implant and the report. There were no reported diagnostics. The patient was trying to find a physician to explant the device. The patient had an appointment on (b)(6) 2017. It was unknown if a surgical intervention was planned but the reporting manufacturer representative was going to follow-up for this information. The patient¿s weight and medical history was asked but would not be made available. It was unknown in what context the event occurred (during normal use, intra-operatively, etc. ) but the reporting manufacturer representative was going to follow-up for this information.
 
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 representative on 2017-03-17 reporting that the manufacturer representative was not aware of what made the patient think that they had an infection. This event occurred during normal use. The patient had contacted a health care professional (hcp) who would remove their device and would have it cultured. The date of the surgery was unknown.
 
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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 Key6413064
MDR Text Key102131304
Report Number3004209178-2017-05819
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
Remedial Action Notification
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 11/15/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/17/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/14/2017
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 Received10/19/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/16/2016
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: 03/17/2017 Patient Sequence Number: 1
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