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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 Problem Excess Flow or Over-Infusion (1311)
Patient Problems Flatus (1865); Muscular Rigidity (1968); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/01/2021
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a foreign healthcare professional (hcp) via a distributor regarding a patient receiving intrathecal baclofen (unknown concentration) at 80 mcg/day via an implantable pump for spinal cord injury. It was reported that when refilling in an outpatient setting, the expected reservoir volume (erv) was 4. 9 ml, but the actual reservoir volume (arv) was only 0. 5 ml. In order to confirm puncture, 18 ml of normal saline was injected, and when suction was taken again, more than 17 ml was drawn, so it was judged that there was no problem with puncture. 18 ml of gabalon medullary injection 0. 1% was injected. It was noted that the degree of spasticity seemed to vary from day to day, but there were no particular symptoms of overdose. To be sure, the dosage was reduced by 20% (to 64 mcg/day), and the refill would be done again next month (from (b)(6) 2021) for confirmation. The abnormal fluctuation rate was considered recovered on (b)(6) 2021. The causality of the issue was reportedly not related to the drug, catheter, pump, or programmer. It was unknown if the causality was related to the surgical procedure.
 
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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 Key12125090
MDR Text Key265987092
Report Number3004209178-2021-10435
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 company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/17/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/06/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/14/2017
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 Received07/16/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/15/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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