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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 Misconnection (1399); Protective Measures Problem (3015)
Patient Problems Abdominal Pain (1685); Cerebrospinal Fluid Leakage (1772); Muscle Weakness (1967); Muscular Rigidity (1968); Pain (1994); Seroma (2069); Weakness (2145); Headache, Lumbar Puncture (2186); Discomfort (2330); Complaint, Ill-Defined (2331); Fluid Discharge (2686)
Event Date 09/20/2018
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: 8780, serial#: (b)(4), implanted: (b)(6) 2018, product type: catheter. Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 16-may-2020, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
On (b)(6) 2019, information was received from an healthcare professional (hcp) regarding a patient receiving an unknown drug via an implantable pump for spinal pain. Information received reported a catheter event. The hcp stated the patient showed up at the facility for the first time stating they wanted the pump explanted. The pump was implanted in (b)(6) 2018 and the catheter tip was placed at t8-9 location. The hcp stated that the patient has had "a lot of problems with the catheter potentially not attached correctly". The hcp thought prialt was in the system and for 2. 5 months, the patient was in the hospital. The hcp stated that this information was all hear-say. The hcp stated they did not know what, if any drug, was currently in the pump. A computed tomography (ct) scan with contrast of the lumbar spine was done on (b)(6) 2018 and a cerebrospinal fluid (csf) leak was discovered per the medical report. The following day, a post-ct myelogram reports showed an unchanged collection of csf at the l2-4 at the laminectomy level. The hcp confirmed the catheter was there at that time. The hcp stated the original or report when the pump and catheter were implanted ((b)(6) 2018) stated the patient had really deep fascia and scar tissue over the intrathecal (it) sac with good return of csf. The hcp stated the patient was told by their previous hcp that the patient's "body absorbed the catheter". The date of this was not known. The patient did have an magnetic resonance imaging (mri) performed on (b)(6) 2019 and it was determined upon examination, there was no catheter in the area of the patient's body. The hcp inquired about what diagnostics could be done for the catheter as they were trying to determine if they wanted to explant the patient's pump not knowing the condition of the catheter.
 
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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
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key8545737
MDR Text Key143246270
Report Number3004209178-2019-08182
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P860004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/24/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2020
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 Received08/24/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured09/06/2018
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: 04/24/2019 Patient Sequence Number: 1
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