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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

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MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE Back to Search Results
Model Number 8637-20
Device Problems Material Too Rigid or Stiff (1544); Device Operates Differently Than Expected (2913)
Patient Problems Undesired Nerve Stimulation (1980); Pain (1994)
Event Date 01/19/2017
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id 8781 lot# n633900001 serial# implanted: (b)(6) 2017 explanted: product type catheter product id 8781 lot# n633900001 serial# implanted: (b)(6) 2017 explanted: product type catheter. 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 foreign healthcare provider (hcp) via a manufacturer representative regarding a patient who was receiving gabalon at an 0. 05% at 30 mcg/day in an intrathecal drug delivery pump for spinocerebellar degeneration (hereditary spastic paraplegia). It was reported that on (b)(6) 2017 a pump implantation was conducted from around 14:00 on the day. The catheter implantation site was th9 (reported as catheter replacement). The operation procedure was completed at 17:00 without any issues. It was noted that the higher position of the insertion location was th/l1 and the lower position as close to the lower end of the l1 spinal cord region. It was reported that the patient complained about foot pain, a pain in their little toes, around the pinky toe, and soles when they were back in their room. It was reported that the pain was l5/s1 pain in the lower left leg that started immediately after the first surgery. There was no reported paralysis. The patient was followed-up with until the next morning. The patient¿s pain was eased the next morning on (b)(6) 2017, however, the ¿pain observed repeatedly afterwards¿. The physician decided that the ¿patient to be followed up¿ until around 15:30 on monday. Initially, this pain was reported as not related to the investigational drug, catheter, pump and programmer but it was unknown if it was related to the surgical procedure. Further, the relationship to itb therapy was not thought to be strong because the patient already had a slipped, displacement, of the l5 vertebra before the surgery. Therefore, it was believed that the patient's posture during the surgery may have been related to the pain. It was reported that it was considered that the therapy was remotely related with the reported pain and on (b)(6) 2017 it was reported that this was related to the catheter and surgical procedure. Motor paralysis was not observed. The pain was temporarily improved by a l5/s1block. Since this was only temporary, epidural anesthesia was performed. As pain improvement was not observed, pressure due to the catheter at the cauda equina was suspected and catheter explant was conducted. Right after the procedure, the pain immediately disappeared. A spinal ct was done immediately after the surgery and a catheter was inserted from between th12/l1, but no particular spinal compression was discovered. So, it was decided that the epidural anesthesia would be carried out followed by observation. The physician assessment indicated the implant site was as high as th12/l1 and "conus medullaris was near lower end of conus medullaris. " it was further indicated that before catheter explant, the pain resolved due to opening up the "wounded area" with local anesthetic and loosening the anchoring device. The pain was considered to be a result of cauda equina nerve compression due to the catheter, rather than contact with the catheter. It was further stated another contributing factor was that the catheter was stiffer that the previous one. It was noted that the drug administration was discontinued on (b)(6) 2017. The event outcome was considered recovered as of (b)(6) 2017.
 
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
Initially information was reported that it was further stated that another contributing factor was that the catheter was stiffer that the previous one. The information should have been reported as that it was further stated that another contributing factor was that the ascenda catheter was stiffer that the previous one.
 
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Brand NameSYNCHROMED II
Type of DevicePUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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 clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key6326980
MDR Text Key67282563
Report Number3004209178-2017-03744
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
P860004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/14/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/13/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/14/2017
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/20/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured05/17/2016
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: 02/13/2017 Patient Sequence Number: 1
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