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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 Improper or Incorrect Procedure or Method (2017); Infusion or Flow Problem (2964)
Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/16/2022
Event Type  malfunction  
Event Description
Information was received from a healthcare provider (hcp) via a company representative regarding a patient receiving morphine (30 mg/ml at 8. 494 mg/day) and bupivacaine (15 mg/ml at 4. 247 mg/day) via an implanted pump. It was reported that the patient thought his pump would last until his refill date even though he was hearing the alarm, so he did nothing about it and the pump went to end of service (eos). The patient experienced withdrawal symptoms and went to the emergency room. The pump was interrogated and confirmed to be at eos and no longer delivering drug. The patient was taken to surgery to replace the pump. During the procedure, the catheter was unable to be aspirated the recommended 1-2 cc through the cap (catheter access port) chamber. The hcp asked if he could push saline through the cap chamber and it was discussed that it wasn't recommended because he could potentially bolus the patient because it was unknown how much drug was in the catheter due to the pump reaching eos and being off for a significant period of time before the replacement. A back table prime of the new pump was started. During the back table prime of the new pump, the hcp decided to replace the pump segment of the catheter. After the back table prime, he wanted to prime the entire volume of the revised catheter. It was discussed that this would potentially bolus the patient; however, the hcp decided to proceed with the prime. The patient was taken to the icu (intensive care unit) for observation following the procedure. The next day, the patient was doing well in the icu and would continue to be monitored. It was unknown if the issue was resolved, and it was indicated that the hcp had no further information to provide regarding the event.
 
Manufacturer Narrative
Concomitant medical products: product id: 8780, serial# (b)(4), implanted: (b)(6) 2015, explanted: (b)(6) 2022, product type: catheter. Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 16-jan-2017, udi#: (b)(4). Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803. This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda. Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report. This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report. In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿. These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting. Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms. This statement should be included with any information or report disclosed to the public under the freedom of information act. Any required fields that are unpopulated are blank because the information is currently unknown or unavailable. A good faith effort will be made to obtain the applicable information relevant to the report. 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 Key14769801
MDR Text Key294638599
Report Number3004209178-2022-07953
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
Report Date 07/11/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/22/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/28/2016
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/07/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured05/28/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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