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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 Problems Infusion or Flow Problem (2964); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Muscular Rigidity (1968); Pain (1994); Cramp(s) /Muscle Spasm(s) (4521)
Event Date 01/22/2021
Event Type  malfunction  
Event Description
Information was received from a healthcare provider regarding a patient receiving unknown baclofen ( 500 mcg/ml at 145. 21 mcg/ml) via an implanted infusion pump. The indication for use was intractable spasticity. It was reported the last two times the patient had refills there were volume discrepancies. On (b)(6) 2021, the hcp was expected 3ml and got back 5 ml and on (b)(6) 2021 they were expecting 3. 5 ml and removed 8 ml. Caller noted that they have done a couple of 10% dose increases because the patient reported some increased pain around mid back and being tighter in general with spasms when starting to push. The issue was not resolved through troubleshooting. Additional information was received from the device manufacturer representative indicated that the received a catheter dye study today and they were unable to aspirate. It was reported that they continued to increase the patient's daily rate and at refills there was a significant variance of 4. 1 expected drug and 8. 2 actual drug withdrawn at refills.
 
Manufacturer Narrative
Concomitant medical products: product id: 8709sc, 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 Key14161078
MDR Text Key289690041
Report Number3004209178-2022-05009
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 Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/22/2022
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 Date08/14/2019
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/21/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured02/21/2018
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: 04/20/2022 Patient Sequence Number: 1
Treatment
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