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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 Problem Insufficient Information (3190)
Patient Problems Pain (1994); Therapeutic Response, Decreased (2271); Distress (2329); Sedation (2368)
Event Date 01/28/2020
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare professional (hcp) via a clinical study regarding a patient receiving hydromorphone 2. 5 mg for a total dose of 0. 86045 mg/day, bupivacaine 30 mg for a total dose of 10. 32541 mg/day, and compounded baclofen 150 mcg for a total dose of 51. 62704 mcg/day via an implantable pump. It was reported on (b)(6) 2020 the intrathecal (it) rate was increased secondary to increased pain following intrathecal rate decrease. On (b)(6) 2020 the patient came to the clinic with acute opioid withdrawal symptoms including emotional distress and severe pain. A catheter access port (cap) dye study was performed and revealed a normal functioning catheter. A pump malfunction was suspected. The patient was given hydromorphone 8 mg by mouth, ativan 1 mg by mouth, and clonidine 0. 1 mg by mouth. The it rate was decreased. The patient was monitored for 3 hours secondary to sedation. Pump replacement was ordered. The patient was started on a 25 mcg fentanyl patch, clonidine 0. 1 twice daily for withdrawal, and lorazepam daily as needed on (b)(6) 2020. On (b)(6) 2020 the pump was explanted/replaced. The outcome of the event resolved without sequelae on (b)(6) 2020. The device diagnosis was other suspected pump malfunction and the clinical diagnosis was it opioid withdrawal. The etiology of the event indicated the relationship of the event to the device or therapy was related and indicated the relationship of the event to the implant procedure was not related. The relatedness to the drug (hydromorphone, bupivacaine, and baclofen) was related and the drug action that caused the event was decreased dose. The event date was (b)(6) 2020. No further complications were reported.
 
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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 Key9974560
MDR Text Key188115301
Report Number3004209178-2020-07347
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,study
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/17/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/14/2019
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/20/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/14/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/20/2017
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: 04/17/2020 Patient Sequence Number: 1
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