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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); Material Integrity Problem (2978)
Patient Problems Pain (1994); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 04/20/2022
Event Type  Injury  
Event Description
Information was received from a consumer and healthcare provider (hcp) via a company representative (rep) regarding a patient receiving intrathecal dilaudid 1 mg/ml at 0. 220 mg/day via an implanted pump. It was reported the patient was reporting no pain relief after the last pump refill. There were no identified environmental/external/patient factors that may have led or contributed to the issue. The patient was scheduled for a catheter dye study on (b)(6) 2022 and cerebrospinal fluid (csf) could not be aspirated through the catheter access port (cap). The doctor asked the patient if she had any recent falls and when she noticed the loss of therapy. It was noted it was after her most recently pump refill. The issue was not resolved at the time of this report and the patient¿s status was ¿alive- no injury¿. It was further reported surgical intervention was planned but had not been scheduled. The patient¿s weight and medical history were asked but unknown.
 
Manufacturer Narrative
Concomitant medical products: product id 8780, serial#: (b)(4), implanted: (b)(6) 2021. Product id: 8780, serial/lot #:(b)(4), ubd: 02-jul-2023, 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 Key14210441
MDR Text Key290092194
Report Number3004209178-2022-05254
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 Initial,Followup
Report Date 06/15/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/26/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/14/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured08/02/2021
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: 04/26/2022 Patient Sequence Number: 1
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