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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 Detachment of Device or Device Component (2907); Material Integrity Problem (2978)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 05/11/2022
Event Type  Injury  
Event Description
Information was received from a healthcare provider (hcp) regarding a patient receiving gablofen (2000 mcg/ml at 150 mcg/day), via an implantable infusion pump. The indication for use was unknown. It was reported that the patient experienced suboptimal therapy. The patient was seen for early replacement indicator (eri) pump replacement. The catheter appeared to be fractured at the fascia level where it would enter into the intrathecal space. No catheter tip was found. The catheter was replaced on (b)(6) 2022. It was unknown if there were any environmental/external/patient factors that contributed to the event. It was unknown if troubleshooting was performed. The status of the patient at the time of the report was ¿alive ¿ no injury¿. The patient's weight and medical history were asked but was unknown. The issue was resolved at the time of the report.
 
Manufacturer Narrative
Concomitant products: product id: 8731, serial#: (b)(4), implanted: (b)(6) 2004, explanted: (b)(6) 2022, product type: catheter. Other relevant device(s) are: product id: 8731, serial/lot #: (b)(4), ubd: 14-jul-2006, 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 Key14429676
MDR Text Key291932800
Report Number3004209178-2022-06324
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 07/26/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/18/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/28/2018
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 Received07/22/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/29/2016
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: 05/18/2022 Patient Sequence Number: 1
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