• 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 8637-40
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problems Low Blood Pressure/ Hypotension (1914); Cognitive Changes (2551)
Event Date 10/31/2018
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: product id: a810, product type: software. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the healthcare provider (hcp) via a company representative (rep) indicated the patient¿s weight at the time of the event was unknown. It was noted it seemed to be a simple decimal point error. The reporter was not at the case and got involved the next day post operative and noticed the error, due to the refill date being in three days. The new tablet was being used at the time of the event. No further complications were reported/anticipated or expected.
 
Manufacturer Narrative
Concomitant medical products: product id: neu_unknown_prog, serial# unknown, product type: programmer, physician. Other relevant device(s) are: product id: neu_unknown_prog, serial/lot #: unknown. 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 (rep) regarding a patient receiving intrathecal unknown morphine 1. 3 mg/ml at 1. 8 mg/day via an implanted pump for non-malignant pain and chronic low back pain. It was reported the drug dose was entered incorrectly and the patient¿s pump was incorrectly programmed during the time of the implant on (b)(6) 2018. The dose was programmed to 1. 8 mg/day and was supposed to be 0. 18 mg/day. The rep was with the patient to update the pump back to the correct 0. 18 mg/day (resolved). It was noted the patient had low blood pressure (no intervention) and was feeling groggy (potentially from surgery on (b)(6) 2018). Troubleshooting resolved the reported issue. The rep was also walked through how to resync the new ptm to the patient¿s pump after an error dose was changed to the correct dose and the ptm was able to be resynched. No further complications were reported/anticipated or expected.
 
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 Key8038600
MDR Text Key126282332
Report Number3004209178-2018-24680
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,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/06/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/05/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2020
Device Model Number8637-40
Device Catalogue Number8637-40
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 Received11/05/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured09/04/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-