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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 Pumping Stopped (1503); Battery Problem (2885); Infusion or Flow Problem (2964)
Patient Problems Itching Sensation (1943); Muscle Weakness (1967); Muscular Rigidity (1968); Shaking/Tremors (2515)
Event Date 08/14/2021
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare provider regarding a patient receiving lioresal (500 mcg/ml at 59. 97 mcg/day) via an implanted infusion pump. The indication for use was intractable spasticity. It was reported the patient was in the er last weekend with increased spasticity. The patient thought the pump ran out of drug but was not hearing an alarm. The patient was seen at the clinic yesterday and a refill was done. There were no alarms upon interrogation. Pump logs were no checked. This am the patient stated their pump was alarming. Additional information was received on (b)(6) 2021 from the healthcare provider who reported that the patient¿s pump has had several stalls and recoveries. Per the healthcare provider the patient had an mri but the stalls started 4-5 days after the mri. The stalls happen randomly at different times of the day and when the patient is at different locations. The patient has been stiff one day and loose the next and the patient gets tremors and itching when she is short of medication.
 
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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 Key12405829
MDR Text Key269287088
Report Number3004209178-2021-13187
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 Study,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 01/06/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/01/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/28/2021
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/01/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/06/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/11/2020
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: 09/01/2021 Patient Sequence Number: 1
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