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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 Infusion or Flow Problem (2964); Protective Measures Problem (3015)
Patient Problems Pain (1994); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 04/08/2022
Event Type  Injury  
Event Description
On (b)(6) 2022, information was received from an healthcare professional (hcp), via a manufacturer representative (rep), regarding a patient receiving dilaudid (30 mg/ml, 4. 5 mg/day), bupivacaine (20 mg/ml, 3 mg/day) fentanyl (100 mcg/ml, 150 mcg/day) and clonidine (100 mcg/ml, 15 mcg/day) via an implantable pump. It was reported the patient was new to the hcp. The patient presented for a normal pump refill procedure, but the hcp decided to also perform a catheter dye study because of the contents of the pump and the patient had complained of still having pain. The expected reservoir volume (erv) was 3. 6 ml and the actual reservoir volume (arv) was 3. 0 ml. The pump was then filled with 20 ml of sufentanil (50 mcg/ml). The catheter access port (cap) was then accessed. The hcp easily drew back 3 ml of fluid, injected contrast and used x-ray to visualize the catheter. They were unable to visualize the catheter. They were able to see the tip of the catheter, but there was no dye exiting the top of the catheter. The hcp injected a second time and still no dye was moving to make the catheter visible. The hcp decided to place the pump on minimum rate at 0. 297 mcg/day (0. 012 mcg/hr). The patient was scheduled for revision. They would supplement with oral medication until revision surgery on (b)(6) 2022. The issue was not resolved at the time of this report.
 
Manufacturer Narrative
Concomitant medical products: product id 8780, serial# (b)(4), implanted: (b)(6)2013, product type :catheter, ubd: 28-feb-2015, 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 Key14106260
MDR Text Key289223328
Report Number3004209178-2022-04700
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 05/25/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/13/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/28/2021
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/24/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured01/03/2020
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: 04/13/2022 Patient Sequence Number: 1
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