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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 Obstruction of Flow (2423); Infusion or Flow Problem (2964); Material Integrity Problem (2978); Patient Device Interaction Problem (4001)
Patient Problems Itching Sensation (1943); Muscular Rigidity (1968); Scar Tissue (2060); Convulsion/Seizure (4406); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 03/16/2021
Event Type  Injury  
Event Description
Information was received from a healthcare provider (hcp) and consumer via a company representative (rep) regarding a patient receiving intrathecal lioresal 2000mcg/ml at 246 mcg/day to 100 mcg/day via an implanted pump. It was reported the patient had symptoms of withdrawal on and off since his pump replacement last year (b)(6) 2021 and has had issues every since. Symptoms included itching and increased spasticity, but not severe withdrawal. There were no known environmental, external, patient factors that may have led or contributed to the issue. In the last month, the patient had a cat scan and attempted aspirations to the side board that revealed no flow. It was further reported the patient was taken to the operating room (or) on the date of this report, and the pump pocket opened with no cerebrospinal fluid (csf) through the side port. It was noted there was a large entanglement of catheter in scar tissue that was found at the bottom of the pump pocket surrounding the catheter access port. Large amounts of scar tissue was invading the catheter connector as well. The catheter was cut and still no csf flow. Once the catheter was untangled, and it was cut proximal to the collet, csf began to flow. A new catheter connector was placed with good csf flow, and a new 20 ml pump was placed, and dose reduced from 246 mcg/day to 100 mcg/day. Patient did have an intra-operative seizure. Patient would be admitted to the intensive care unit (icu) because of dose change and intraoperative seizure observed. It was noted the patient¿s old pump was assessed to see if there was the proper amount of medication remaining. There was the exact amount of medication as expected, therefore the pump was delivering medication somewhere. It was unknown if the issue was resolved at the time of this report and the patient¿s status was ¿alive- no injury¿. The patient¿s weight was asked and would not be made available.
 
Manufacturer Narrative
Continuation of concomitant medical products: product id 8780, serial# (b)(4), implanted: (b)(6) 2014, product type: catheter , ubd: 12-aug-2016, udi#: (b)(4). 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 Key13761937
MDR Text Key289462903
Report Number3004209178-2022-03241
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 Consumer,Health Professional,Company Representative
Reporter Occupation
Type of Report Followup,Followup
Report Date 05/26/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/14/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/14/2022
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/19/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/17/2020
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: 03/14/2022 Patient Sequence Number: 1
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