• 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 Fatigue (1849); Complaint, Ill-Defined (2331); Sedation (2368); Cognitive Changes (2551)
Event Date 04/26/2018
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 health care professional (hcp) via a representative regarding a patient in canada who received hydromorphone 10mg/ml, dose unknown, bupivacaine 26mg/ml dose unknown, and baclofen 140mcg/ml dose unknown. The indication for use was not provided. It was reported that on (b)(6) 2018 during a routine device follow-up for an intrathecal pump refill an unexplained pocket fill occurred. The pump was accessed and a sinking feeling and scraping of the back of the tank with the needle was felt. Once accessed, a registered nurse colleague held the needle in place in the tank reservoir with significant downward pressure. The ¿writer¿ withdrew 3. 9ml of old medication (within patient norm) and then the pump was refilled with 40ml of medication with the same concentrations as prior (hydromorphone 10mg/ml. Bupivacaine 26mg/ml, baclofen 140mcg/ml). The pump was programmed with same dosing as prior. Almost immediately, the patient started feeling "spacy". A "blanket of heaviness" over her upper body. The patient sedated. The physician in the clinic was immediately notified. On ultrasound, no fluid collection was seen above the pump access port. The pump was re-accessed and 38. 7 ml of drug was removed which left 1. 3ml unaccounted for. As reported, however, there was approximately 0. 5ml used to prime the filter, and 0. 1ml to prime the extension tubing which did not enter the patient¿s tank. The patient remained in the clinic with close and constant care until 4pm that day. Vitals were taken every 15 minutes and remained stable, including oxygen saturations and respiratory rate. The patient was drowsy but easily rousable, conversed appropriately, ate lunch, visited with nurses and spouse. The patient was discharged after a final assessment by the physician. The patient was in ¿good condition¿, although still slightly drowsy. The patient was wheel chair-bound naturally. The patient left with spouse helping push wheelchair. During the day, the procedure was reviewed and tubing examined for faulty clamping. No obvious errors could be identified. At the time of the report, it was unknown if the issue was resolved and the patient¿s status was also unknown. No surgical intervention occurred nor was planned. The device remained implanted and in-service. No further complications were reported/anticipated.
 
Manufacturer Narrative
Manufacturer site id has been updated to #3004209178. If information is provided in the future, a supplemental report will be issued.
 
Event Description
The health care professional later provided that when the 3. 9 ml was withdrawn (actual reservoir volume), 4. 4 ml was the expected reservoir volume. Further, the previous refilled (date not provided) showed when 4. 4ml was expected the actual was 3. 5ml and further previous to that (date not provided) 2. 4ml expected and the actual was 2. 0ml. The recent ¿sinking feeling and scraping of the back of the tank with the needle was felt¿ was considered normal and as reported a confirmation that the needle was deep in the reservoir. The company¿s refill kit was used for the refill. The previous reported sedated was confirmed to be just drowsy. There was nothing planned for further troubleshooting or diagnostic testing as ¿was re-accessed immediately¿ after they suspected a pocket fill. The patient reported they had felt a little sleepy that same evening, but was back to baseline the next day. Regarding resolution to the event, as reported this was not resolved as the missing drops of medication were hard to account for. Further discussion with the representative was to occur. The daily doses of the medications were reported as hydromorphone at 4. 2 mg daily, bupivacaine at 10. 9 mg daily, and baclofen at 58. 79 mcg daily.
 
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 MN 00777 1200
Manufacturer (Section G)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos,pr MN 00777 1200
Manufacturer Contact
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key7501609
MDR Text Key108244919
Report Number3007566237-2018-01399
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
P860004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup
Report Date 05/18/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/09/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/28/2018
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 Received05/10/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/11/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-1060-2011

-
-