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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 Fluid Leak (1250); Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problems Fatigue (1849); Rash (2033); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/29/2021
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare provider (hcp) via a company representative regarding a patient receiving bupivacaine (5 mg/ml at 1. 99875 mg/day), clonidine (100 mcg/ml at 39. 975 mcg/day), and morphine (20 mg/ml at 7. 995 mg/day) via an implanted pump. The indication for pump use was spinal pain. It was reported that the patient¿s pump was malfunctioning. Per the hcp, the patient came in for a refill on (b)(6) 2021 stating that she ¿wasn¿t feeling right¿. They then filled her pump and she began to have a ¿systemic reaction¿ and had a rash near the pump site in the soft tissues. The hcp sent her home and the patient stated that last night she felt drugged, was falling asleep, and was barely able to stay awake. The hcp brought her back in today and took out the medication and put contrast in and realized that the contrast was ¿spraying out of the port¿. The ¿connector port¿ was leaking and he believed that the pump was ¿throwing a bolus by itself¿ and stated that he did not have flex/boluses programmed. The shutdown code to permanently stop the pump was requested and provided during the call.
 
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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
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key11875107
MDR Text Key265901473
Report Number3004209178-2021-08243
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 company representative,consum
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 08/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/25/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/28/2019
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/12/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/04/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/07/2018
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: 05/25/2021 Patient Sequence Number: 1
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