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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 Disconnection (1171); Fluid Leak (1250); Migration or Expulsion of Device (1395); Insufficient Information (3190)
Patient Problems Fever (1858); Muscular Rigidity (1968); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/19/2022
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: 8781, lot#: n515795002, implanted: (b)(6) 2015, product type: catheter. Other relevant device(s) are: product id: 8781, serial/lot #: (b)(4), ubd: 23-dec-2016, udi#: (b)(4). 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 distributor regarding a patient receiving gabalon (unknown concentration at an unknown dose) via an implantable infusion pump. The indication for use was cerebral palsy. It was reported the pump had been replaced on (b)(6) 2022 and there was no particular problem. On (b)(6) 2022, the patient had an outpatient consultation due to a high fever and worsening spasticity. Botulinum toxin (btx) was injected into the lower limbs. The patient was monitored and then went home. On (b)(6) 2022, the patient had a normal temperature and was relieved from tension. The patient went home and would be under observation until the next refill. On (b)(6) 2022, the patient had an outpatient consultation due to worsening spasticity. A refill was performed and there was not an abnormal variability rate. A roller test was performed and it seemed like the pump was working fine, but it was not clear. The patient had tension. A contrast study was attempted, but it was not successful so it was discontinued. The patient went home for observation and adjustment of hospitalization. The patient's hospitalization was re-adjusted on the (b)(6), and after they were to be hospitalized, a roller examination and contrast study would be performed again. The adverse events were considered unrelated to the drug, programmer, and surgical procedure, and unknown if related to the catheter or pump. The attending physician's comments indicated the cause was unknown. Additionally, pump "up/down rotation" was reported. This was considered unrelated to the drug, catheter, pump, and programmer, and unknown if related to the surgical procedure. Further complications were not reported. Additional information was received. On (b)(6) 2022, an "scr" drug formulation was administered via lumbar puncture and was effective. When the system was checked again via x-ray, it seemed that the pump connection was disconnected. After conducting a ct scan, the future plans would be considered by consulting with the neurosurgery department.
 
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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 Key14756797
MDR Text Key295030315
Report Number3004209178-2022-07918
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,Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 07/25/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/21/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/20/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/11/2021
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: 06/21/2022 Patient Sequence Number: 1
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