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

Model Number 8637-20

Device Problem Occlusion Within Device (1423)

Patient Problems Muscle Weakness (1967); Muscular Rigidity (1968); Therapeutic Response, Decreased (2271)

Event Date 01/30/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: neu_unknown_cath, lot# unknown, product type catheter.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a foreign healthcare provider (hcp) via a manufacturer's representative regarding a patient who was receiving compounded baclofen (unknown concentration at 86 mcg/day) via an implantable pump for an unknown indication for use.It was reported that some days the patient experienced returned spasticity and withdrawal symptoms, while some days the patient experienced the opposite (hypotonicity).The event date was provided as (b)(6) 2018.The pump was explanted and replaced on (b)(6) 2018.In the operating room, spinal fluid dripped spontaneously from the catheter, so occlusion was ruled out by the implanter.However, an indium scan showed no indium intrathecally, so a catheter occlusion or pump malfunction was suspected.There were no pump alarms, and the event logs did not show any abnormality.Logs would be sent along with the pump for analysis.It was stated that a temporary occlusion caused by different position of the patient could not be ruled out.There were no contributing factors reported by the patient.The patient status was alive; no injury.No further complications were reported or anticipated.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Analysis of the pump did not reveal any anomalies.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, 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 Key: 7231608
• MDR Text Key: 98696377
• Report Number: 3007566237-2018-00308
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2017
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/30/2018
• Initial Date FDA Received: 01/31/2018
• Supplement Dates Manufacturer Received: 02/15/2018; 03/07/2018
• Supplement Dates FDA Received: 02/15/2018; 03/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention