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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 Contamination (1120); Infusion or Flow Problem (2964)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/08/2021
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id :8780, serial# : (b)(4), implanted: (b)(6) 2015, explanted: (b)(6) 2021, product type: catheter. Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 10-dec-2016, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a company representative (rep) via a healthcare provider (hcp) regarding a patient with an implanted infusion pump receiving morphine and bupivacaine with a concentration of 20 mg/ml diluted to 5 mg/ml and 30 mg/ml diluted down to 7. 5 mg/ml with a dose of 0. 24mg/day and 0. 37 mg/day respectively. It was mentioned during normally scheduled pump replacement, due to nearing end of life of pump, the catheter could not be aspirated. Rep mentioned they tried to trim the pump segment to see if there was any flow from the intrathecal segment, and there was no flow. The healthcare provider (hcp) chose to replace the catheter. While he was connecting the new pump to the new catheter, the pump slid underneath the sterile drape and became contaminated. Therefore a new pump and pump segment needed to be opened and implanted. Patient status at the time of report was alive no injury. Issue was resolved at time of the 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 Key12619287
MDR Text Key277151290
Report Number3004209178-2021-15254
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 12/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/19/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/09/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/27/2021
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: 10/12/2021 Patient Sequence Number: 1
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