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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 Obstruction of Flow (2423); Infusion or Flow Problem (2964)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 04/22/2022
Event Type  Injury  
Manufacturer Narrative
Continuation of concomitant medical products: product id 8780, serial# (b)(4), implanted:(b)(6) 2021, explanted: (b)(6) 2022, product type: catheter, ubd: 05-nov-2022, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
On (b)(6) 2022, information was received from a patient, via a manufacturer representative (rep), regarding a patient receiving compounded baclofen (750 mcg/ml, 150 mcg/day) via an implantable pump. It was reported the patient experienced withdrawal symptoms. A catheter dye study pre-op showed the catheter could not be aspirated. A roller study was satisfactory. Surgical intervention occurred but they were unable to locate the source of the occlusion. The spinal segment of the catheter was removed and the spinal segment was left implanted and tied off. The pump was removed with the intention of re-implanting, but the healthcare professional (hcp) could not get the catheter implanted. The issue was not resolved at the time of this report.
 
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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 Key14222208
MDR Text Key290192565
Report Number3004209178-2022-05336
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,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 05/02/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/27/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/28/2022
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Date Manufacturer Received04/27/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured12/09/2020
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: 04/27/2022 Patient Sequence Number: 1
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