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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 Abdominal Pain (1685); Dyspnea (1816); Fatigue (1849); Muscle Weakness (1967); Neuropathy (1983); Pain (1994); Seroma (2069); Vomiting (2144); Burning Sensation (2146); Therapeutic Response, Decreased (2271); Anxiety (2328); Discomfort (2330); Complaint, Ill-Defined (2331); Malaise (2359); Numbness (2415); Sleep Dysfunction (2517); Electric Shock (2554); Lethargy (2560); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 09/09/2020
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: 8709, product type: catheter. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from the healthcare provider via a device manufacturer representative regarding a patient receiving an unknown drug via an implantable infusion pump. It was reported that the patient had been having withdrawals for the past two weeks. The felt "jittery, restless leg, vomiting, and stomach pains. "a dye study was performed but the catheter could not be aspirated. When they accessed the reservoir, they aspirated 20ml and they expected 16. 5ml. The caller stated they are looking to schedule a removal for the full system.
 
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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 Key10592741
MDR Text Key208748921
Report Number3004209178-2020-16779
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,Followup
Report Date 12/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/28/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/14/2016
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/02/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/20/2014
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: 09/28/2020 Patient Sequence Number: 1
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