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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 8637-40
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cerebrospinal Fluid Leakage (1772); Fistula (1862); Pain (1994); Scar Tissue (2060)
Event Date 05/04/2021
Event Type  Injury  
Event Description
Citation: dupoiron d, deer t. Dura fistula: a rare complication of simultaneous placement of neurostimulation leads and an intrathecal catheter. Neuromodulation. 2021. 10. 1111/ner. 13464. Summary: we report here an uncommon complication, secondary to the successive use of neurostimulation and intrathecal analgesia in a patient with progression of cancer-causing severe cancer related pain. The patient presented late in the treatment course with a dural fistula, which negatively impacted his outcome. The potential mechanisms are considered, and treatment options are discussed along with potential options for prevention of this poor outcome in future patients.   reported event: at this time, the situation deteriorated rapidly with intractable pain despite an increase in intrathecal dosages to upper limits of acceptable dosing. Evaluation of the idds was implemented with standard x-rays, computed tomography scan with 3d reconstruction that illustrated the catheter position adjacent to the implanted paddle lead, but with no dislodgement, kinking, or breaking of the catheter (figure 1a). In order to understand the dynamic cerebrospinal fluid (csf) flow of the drug, a nuclear imaging study with indium-111 was performed. The imagery displayed the expected indium diffusion inside the csf tracking to the brain (figure 1b) with a denser concentration of spread in the lumbar spine without significant abnormality (figure 1c). To further evaluate the function of the device, a side port myelogram was performed in the operating theater. This imaging revealed a contrast leak from the catheter coursing into the epidural space in an area where csf flow dissipated (figure 2a). The diagnosis of a dura fistula was confirmed and felt to be the etiology. A catheter revision was then performed with removal of the original catheter and replacement below the level of the plate electrode. Fluoroscopy was used to confirm a normal appearing myelogram (figure 2b). The pump was removed, and the catheter connected to a subcutaneous port to allow for more rapid and significant adjustments to the system. For one week, the pain was stabilized, and the neurosurgical team was consulted regarding the dural fistula, but at that time in the context of palliative care no surgical treatment was recommended. One week later, the clinical condition deteriorated rapidly with an uncontrolled level of pain requiring high dose iv opioids and ketamine, which achieved minimal improvement. Fluoroscopic evaluation showed and objective enlargement of the fistula just under the epidural lead further clarifying the clinical situation. As the situation became dire, the patient requested terminal sedation that was then performed following ethical (b)(6)law rules.
 
Manufacturer Narrative
Citation: dupoiron d, deer t. Dura fistula: a rare complication of simultaneous placement of neurostimulation leads and an intrathecal catheter. Neuromodulation. 2021. 10. 1111/ner. 13464 b. 3. Please note that this date is based off of the date that the article was accepted for publication as the event dates were not provided in the published literature. Section d information references the main component of the system. Other relevant device(s) are: product id: 8781, serial/lot #: (b)(4), ubd: (b)(6) 2021, udi#: (b)(4), implanted: (b)(6) 2019 explanted: product type: catheter. If information is provided in the future, a supplemental report will be issued.
 
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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
glen belmer
7000 central avenue ne rcw215
minneapolis, MN 55432
6122713209
MDR Report Key12796463
MDR Text Key284282133
Report Number3004209178-2021-16845
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
P860004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Literature,Health Professional
Reporter Occupation
Type of Report Initial
Report Date 11/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/11/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/14/2020
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/26/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured02/15/2019
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: 11/11/2021 Patient Sequence Number: 1
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