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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 Inappropriate or Unexpected Reset (2959); Data Problem (3196)
Patient Problems Pain (1994); Malaise (2359)
Event Date 08/18/2021
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) regarding a patient receiving fentanyl (2000 mcg/ml at 499. 9 mcg/day) and bupivacaine (30 mg/ml at 7. 494 mg/day) via an implanted pump. The indication for pump use was malignant pain. The home health nurse reported that she was seeing the patient today to increase her dose and upon interrogation she noted that a reset, safe state, and a pump memory error occurred. She checked the pump logs and they showed that the alarms occurred on (b)(6) 2021. The patient had heard her pump alarming for some time and had increased pain over the course of the last 2 weeks and was taking oral pain meds. The patient was last seen by her hcp (healthcare provider) on (b)(6) 2021 for a cap (catheter access port) procedure. Additional information was received on 27-aug-2021 from the patient¿s managing hcp who reported that today when the pump was interrogated service codes 87 (pump in safe mode) and 101 (pump reset) appeared and the patient was reporting symptoms of feeling awful and her pain returning. The event logs showed the pump reset to minimum rate mode. During the call, the hcp attempted to program the pump out of safe state (minimum rate) and in trying to do so another service code popped up stating that eri (elective replacement indicator) would occur before the next refill. It was noted that the patient heard the alarm, but it seemed to be faint to her. The hcp asked for and was provided the pump off passcode to permanently shut the pump off.
 
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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 Key12539361
MDR Text Key273546337
Report Number3004209178-2021-14481
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
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/28/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/28/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/14/2018
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/28/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/25/2017
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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