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

Model Number 8637-40

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Device Embedded In Tissue or Plaque (3165); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/12/2016

Event Type  malfunction  

Event Description

Information was received from multiple sources (manufacturer representative, healthcare provider) regarding a patient who was receiving normal saline via an implantable pump for non-malignant pain and chronic low back pain.It was reported that hcp stated pump therapy stopped working so elected to not get pump. after attempting different opioids, the decision was made to not continue with the therapy.The issue was resolved at time of report.Patient medical history includes acid reflux, copd, high cholesterol, migraines, tonsillectomy, hysterectomy, cholecystectomy, cataract surgery, appendectomy, lumbar radiculitis, fibromyalgia, cervical rad iculopathy, myofascial pain, osteoarthritis,neck surgery.Additional information stated after pump explanted, it was unable to silence 6 tone alarm immediately followed by 10 tone alarm that activated every one minute.It was also unable to obtain any catheter link documentation nor drug information that was documented in pump with samsung tablet.Rep was able to turn pump off to silence alarms and able to access documented implanted length and medication screen.Documented length pump segment implanted 49.5 cm, measured explanted length 15 cm.This calculates 234.5 cm pump segment remaining in patient's torso.Documented leg spinal segments implanted 48.9 cm, explanted length cut off at 48 cm markand additional measured 4 cm of thinner outer diameter catheter (spinal segment) which in appearance looked stretched, explanting physician  notified of length which remains implanted in patient's torso.Documented medication was normal saline.Documented infusion and mode stopped pump stated pump shut off for 1092 hours 15 minutes.  additional information stated implanted length of catheter which remained in patient was 34.5 cm.

Manufacturer Narrative

Pump and catheter were returned for analysis, analysis found hole not user related and coring tears-cuts in seal on the catheter and low battery reset-undetermined cause on the pump.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): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• Manufacturer (Section G): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 13536476
• MDR Text Key: 287267426
• Report Number: 3004209178-2022-02066
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2012
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/05/2011
• 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 Age: 67 YR
• Patient Sex: Female
• Patient Weight: 91 KG