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

Model Number 8637-40

Device Problems Volume Accuracy Problem (1675); Insufficient Flow or Under Infusion (2182); Communication or Transmission Problem (2896); Infusion or Flow Problem (2964)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/19/2018

Event Type  Injury  

Manufacturer Narrative

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 receiving gablofen (1000 mcg/ml, 300 mcg/day) via an implantable infusion pump for the treatment of intractable spasticity an head/brain injury. New drug dosage would be 325 mcg/day). It was reported that actual reservoir volume (arv) was greater than expected reservoir volume (erv). On (b)(6) 2018, arv was 15 (ml) and erv was 3. 7 (ml). On (b)(6) 2018, arv was 15. 5 (ml) and erv was 2. 5 (ml). Refills prior to (b)(6) 2018 showed no volume discrepancies. The patient had no falls or trauma that they know of that might have contributed to the change. X-ray was done and showed no issue. No patient symptom was reported. No further complication was reported.

Manufacturer Narrative

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

Event Description

Additional information was received from the healthcare provider (hcp). It was reported that the cause of volume discrepancy was not determined. The hcp would be doing a side port aspiration on (b)(6) 2018 to check catheter. Baclofen x-ray of pump was performed to check pump and connection sites. The catheter was still in patient and was being monitored. No further complication was reported.

Manufacturer Narrative

Continuation: product id 8782 lot# serial# (b)(4) implanted: 2017-(b)(6) explanted: product type catheter product id 8784 lot# serial# (b)(4) implanted: 2017-(b)(6) explanted: 2018-(b)(6)product type catheter section information references the main component of the system. Other relevant device(s) are: product id: 8782, serial/lot #: (b)(4), ubd: (b)(6)-2018, udi#: (b)(4) section information references the main component of the system. Other relevant device(s) are: product id: 8784, serial/lot #: (b)(4), ubd: (b)(6)-2018, udi#: (b)(4): due to imdrf harmonization, any previously submitted device, method, result, and conclusion codes no longer apply to this event. If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a healthcare provider (hcp) via a device manufacturer representative. It was reported that the patient had difficulties since the original pump and catheter were placed. The pump had evidently always had difficulties when interrogated which occurred again pre-operation on 2018-(b)(6). The programmer took a while to find the pump event though it was clearly visible and not implanted deep at all. Furthermore, when the pump was being read, it would intermittently drop off and ask for the head to be repositioned. There was a slow interrogation. The patient had escalating dosage since implantation and during last refill, expected reservoir volume (erv) was 4cc while actual reservoir volume (arv) was 12cc. Side port aspiration was unsuccessful. Surgical intervention was performed. Old catheter did not flow in surgery and was then cut in the back incision after which cerebrospinal fluid (csf) began. Hcp then replaced the old pump segment and pump. He then tested the catheter via the side port and the catheter was patent once again. It was unknown if any environmental/external/patient factors that may have led or contributed to the issue. The issue was resolved and patient status was alive with no injury at the time of the report. The pump was later returned with no new information. No further complication was reported.

Manufacturer Narrative

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

Manufacturer Narrative

Analysis found procedural non-conformance of catheter body kink observed. 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 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 Key: 7626683
• MDR Text Key: 112049506
• Report Number: 3004209178-2018-14040
• 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: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 05/28/2018
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2018
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/08/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/05/2016
• 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: 06/21/2018 Patient Sequence Number: 1