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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 Insufficient Flow or Under Infusion (2182); Obstruction of Flow (2423); Infusion or Flow Problem (2964)
Patient Problems Muscular Rigidity (1968); Cramp(s) /Muscle Spasm(s) (4521)
Event Date 11/01/2021
Event Type  Injury  
Manufacturer Narrative
Continuation of concomitant medical products: product id 8711, serial# (b)(4), product type: catheter , ubd: 10-dec-2009, 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 who was receiving gabalon via an implantable infusion pump for vascular disease of spinal cord. The dosing period was (b)(6) 2008 to ongoing. The concentration of gabalong and dose rate was not specified. Complications and medical history / history of side effects was indicated as having been none. There were no concomitant medications. It was reported that the pump was replaced on (b)(6) 2021 and no abnormality variability was observed in the refill prior to replacement. A refill was performed in (b)(6) 2021 and there was no problem. A refill was performed in (b)(6) 2021 and variability rate was 30. 9%. It was noted that progress was observed. It was also reported that the onset of the abnormal variability rate was approximately (b)(6) 2021 and the patient was under observation. The date (b)(6) 2021 is considered an approximate date of event (specific month and year known only). Since then, the dosage had also been increasing. The refill this time resulted in almost 18 ml remaining from the total dosage. X-ray imaging could not confirm if there were abnormalities in the catheter, etc. No withdrawal symptoms were observed but the patient¿s spasticity worsened. A refill was performed in (b)(6) 2022, and the next time the patient was scheduled to see a physician due to high variability rate. A refill was performed on (b)(6) 2022 and the residual volume was just over 18ml. Variability rate was 100%. There was no problem with the event log, no pump alarm. A rotor test, catheter contrast test, etc. Was to be performed during the next hospital visit on (b)(6) 2022. Additional information later received indicated that after conducting the roller test, it was confirmed that the motor had rotated. There were no particular abnormalities observed in the event log or roller test. A problem with the catheter was suspected. For the catheter contrast study, drug absorption from the cap was attempted but it could not be withdrawn, so it is believed that the catheter was blocked / occluded for some reason. Catheter reconstruction was scheduled for (b)(6) 2022. It is believed that there was some cause from the catheter, so a causal relationship cannot be ruled out. It was further noted that the pump and others might not be related. It was indicated that the causal relationship with the pump was none. The relationship of the event to drug, programming, or procedure was unrelated / none. The relationship of the event with the catheter was unknown. The outcome of the event was not recovered.
 
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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 Key14162681
MDR Text Key289697518
Report Number3004209178-2022-05020
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
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 07/22/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/20/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/14/2022
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/21/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/21/2020
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: 04/20/2022 Patient Sequence Number: 1
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