• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE Back to Search Results
Model Number 8637-20
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Muscular Rigidity (1968); Therapeutic Response, Decreased (2271); Sleep Dysfunction (2517)
Event Date 01/17/2020
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from the consumer via a device manufacturer representative regarding a patient receiving baclofen (2000 mcg/ml at 170. 8 mcg/day) via an implantable infusion pump. It was reported that post replacement surgery the patient had some spasticity and trouble sleeping. The patient's mother was concerned that her he may be having withdrawals. The issue was unresolved and the patient was alive with no injury. No further complications have been reported as a result of this event.
 
Manufacturer Narrative
Review of this mdr and/or additional information received shows that there is no information to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury or that the device in this report has malfunctioned. Therefore, this event no longer meets the reporting requirements stipulated in 21 cfr 803. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a manufacturer representative on 2020-feb-06. It was reported that the hcp talked to the mother of the patient and told her to supplement baclofen orally. The symptoms subsided and the pump was functioning normally.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key9644140
MDR Text Key185671472
Report Number3004209178-2020-02132
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
PMA/PMN Number
P860004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 03/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/29/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/14/2021
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/06/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured09/23/2019
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: 01/29/2020 Patient Sequence Number: 1
-
-