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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 Excess Flow or Over-Infusion (1311); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/17/2022
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: product id 8731,serial# (b)(4), implanted: (b)(6)2004, product type :catheter; product id 8596sc , serial#(b)(4), implanted: (b)(6) 2011, product type: catheter. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a company representative (rep) regarding a patient receiving bupivacaine (15 mg/ml at 4. 124 mg/day) and hydromorphone (30 mg/ml at 8. 249 mg/day) via an implanted pump. The indication for pump use was non-malignant pain. It was reported that the company representative (rep) wanted to know the volume of the extension tubing. The rep stated that they expected 38. 5ml and aspirated 35ml from the reservoir. The rep stated that they will monitor for volume discrepancies and patient symptoms and will look into catheter diagnostic testing if need be.
 
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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 Key14025346
MDR Text Key289180539
Report Number3004209178-2022-04337
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 Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/06/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/06/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/28/2019
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/05/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/05/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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