MAUDE Adverse Event Report: RICE CREEK MANUFACTURING SYNCHROMED EL; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number 8627L18

Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems Cerebrospinal Fluid Leakage (1772); Chest Pain (1776); Dyspnea (1816); Edema (1820); Headache, Lumbar Puncture (2186); Complaint, Ill-Defined (2331); No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

Continuation of concomitant products: product id: 8709, lot# j0177964r, implanted: (b)(6) 2001, product type: catheter.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider (hcp) regarding a patient who was receiving an unspecified drug of unspecified concentration at an unspecified dose rate via an implantable pump for non-malignant pain / other non-malignant pain.It was reported that the patient had her pump removed and however still had the ¿leads¿ (catheter) implanted.Magnetic resonance imaging (mri) information for abandoned catheters was reviewed at the time of the report.The mri procedure was not due to a problem with the patient¿s device or therapy.No patient symptoms were reported regarding the mri.It was indicated that the patient told the hcp that their pump was removed because it was not working correctly for the patient and she wanted to go backto taking oral medication.No out of box failure was reported.It was indicated that the patient had no symptoms.Regarding if there was a sudden or gradual change in therapy/symptoms, not applicable was noted.The date of the event was unknown.No further patient complications have been reported as a result of this event.

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.

Manufacturer Narrative

Update: the previously applied patient code (b)(4) is no longer applicable.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received via a healthcare provider (hcp).Regarding the pump having been removed because it was not working correctly for the patient, it was clarified that it was not working well, and the patient was having side effects and experienced edema of their lower extremity (le), shortness of breath (sob), and chest discomfort with sudden onset.It was further indicated that there was a gradual occurrence over the year before explant and there was concern / question if it was flipping; almost not getting medication then all the sudden a release of medication.The patient had no side effect from pump removal; however, the patient had a spinal leak and headache.They had a repeat surgery to repair the leak.The cause of the pump not working correctly for the patient was indicated as having been unknown.Regarding the initial report of the catheter having been left implanted, it was clarified that the catheter was removed on (b)(6) 2004.The cause of the catheter having been left implanted was further indicated as being not-applicable (was explanted).The patient¿s weight at the time of the event was unknown.Regarding the current status of the explanted devices it was noted as having been explanted in 2004 and they did not have the device.The patient's weight at the time of the event was unknown.

• Brand Name: SYNCHROMED EL
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): RICE CREEK MANUFACTURING; 700 central avenue ne; minneapolis MN 55432
• Manufacturer (Section G): RICE CREEK MANUFACTURING; 700 central avenue ne; minneapolis MN 55432
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7713573
• MDR Text Key: 114817476
• Report Number: 6000030-2018-00059
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/04/2018

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: 06/01/2002
• Device Model Number: 8627L18
• Device Catalogue Number: 8627L18
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/19/2018
• Initial Date FDA Received: 07/24/2018
• Supplement Dates Manufacturer Received: 07/23/2018; 08/08/2018; 08/08/2018
• Supplement Dates FDA Received: 07/25/2018; 10/03/2018; 10/04/2018
• 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