MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number 8637

Device Problems Activation, Positioning or SeparationProblem (2906); Positioning Problem (3009)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 10/05/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8780, serial# (b)(4), implanted: (b)(6) 2018, explanted: (b)(6)2018, product type: catheter. Product id 8782, serial# (b)(4), implanted: (b)(6) 2018, product type catheter. Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4); product id: 8782, serial/lot #: (b)(4). If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a foreign healthcare professional (hcp) via a manufacturer representative regarding a patient receiving intrathecal morphine 1 mg/ml at 1 mg/day [up to 2 mg/day with the personal therapy manager (ptm)] and intrathecal bupivacaine 4. 8 mg/ml at 6. 3 mg/day (up to 9. 3 mg/day with the ptm) via an implantable pump. The indication for use was not reported. It was reported the hcp felt the patient was not getting adequate treatment from the targeted drug delivery (tdd), so they performed a ct scan. They felt the spinal segment may have been in the epidural space; the spinal catheter was implanted epidurally. The distal segment of the spinal catheter was removed, and a new spinal segment was implanted. When the spinal segment anchor was being deployed, it became stuck on the applicator and folded over at the tip (curled over itself). The anchor was removed, and a new anchor was used. Only the back wound was opened, and the rest of the catheter was not removed. The anchor would be returned to the device manufacturer. The distal segment would not be returned as it was discarded by the customer. The issue was resolved. The patient's status was alive - no injury. Environmental, external or patient factors reported that might have led or contributed to the event included the patient having a ¿difficult anatomy with spinal cancer¿. There were no [additional] environmental, external or patient factors reported that might have led or contributed to the event. The patient¿s weight and medical history were unavailable. No further complications were reported.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7980647
• MDR Text Key: 124325346
• Report Number: 3007566237-2018-03078
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 12/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 8637
• Device Catalogue Number: 8637
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2018
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 10/18/2018 Patient Sequence Number: 1