• 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 Problems Premature Elective Replacement Indicator (1483); Battery Problem (2885)
Patient Problem No Known Impact Or Consequence To Patient (2692)
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 consumer regarding a patient who was receiving morphine, baclofen, and one unknown drug (unknown con centration and dose) via an implantable pump. Indication for use was non-malignant pain. The date of the event was unknown. It was reported the pump battery failed. The healthcare provider had been increasing the drug. The pump did not last the full amount of time for normal battery depletion. No further complications were reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received via saol. It was reported the patient is caucasian and was(b)(6) at the time of the event onset. On (b)(6)2015, the patient started treatment with compounded baclofen 425 ¿g/ml at an unknown dose. Concomitant products included alpha-lipoic acid, vitamin b12, biotin, vitamin c, coq-10, vitamin b2, vitamin d3, cytomel (liothyronine sodium), flonase (fluticasonepropionate), levoxyl (levothyroxine sodium), magnesium, maxalt (rizatriptan benzoate), milk thistle, nifedipine, nystatin/triamcinolone,ondansetron, pataday (olopatadine hydrochloride), promethazine, promethegan (promethazine), relistor (methylnaltrexone bromide),senokot, skelaxin (metaxalone), trazadone, vivelle-dot (estradiol), voltaren (diclofenac sodium), "vsl #3," wellbutrin (bupropionhydrochloride) and zenpep (pancrelipase). Medical history included non-malignant pain, chronic pain (20 years), nerve pain following laminectomy (2011). On an unreported date, she started treatment with hydromorphone 1000 ¿g/ml at 132. 3 ¿g/day.
 
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 Key7267644
MDR Text Key100056094
Report Number3004209178-2018-03220
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 consumer,other
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/09/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/13/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/14/2015
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/30/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured05/16/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-