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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 Migration or Expulsion of Device (1395); Device Ingredient or Reagent Problem (2910); Infusion or Flow Problem (2964); Protective Measures Problem (3015)
Patient Problems Unspecified Infection (1930); Pain (1994); Seroma (2069)
Event Date 02/14/2022
Event Type  malfunction  
Event Description
Information was received from a healthcare provider (hcp) and consumer via a company representative (rep) regarding a patient receiving intrathecal morphine 5 mg/ml at 0. 25 mg/day via an implanted pump. It was reported the patient had little to no pain relief compared to trial. A dye study was performed but was aborted because the catheter was not successfully aspirated due to a potential seroma found. A culture was taken to get tested. The doctor was going to wait for the results before determining the next steps. It was further reported a dye study was performed to insure proper placement of the catheter. The doctor was unable to aspirate the catheter, and continued getting a thick, yellow fluid. He took a culture to get tested and thought it may be a seroma and possibly infected, so dye study was aborted. No sign of catheter tip on fluoroscopy either. It was noted the patient potentially needed a lead revision. The issue was not resolved at the time of this report and the patient¿s status was ¿alive- no injury¿. 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 type: other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 03-sep-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 Key13536876
MDR Text Key286737362
Report Number3004209178-2022-02069
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 Non-Healthcare Professional
Type of Report Initial,Followup,Followup,Followup
Report Date 03/31/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/15/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Date Manufacturer Received03/24/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/27/2021
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: 02/15/2022 Patient Sequence Number: 1
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