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

Model Number 8637-40

Device Problems Volume Accuracy Problem (1675); Improper Flow or Infusion (2954)

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

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 foreign healthcare professional (hcp) via a manufacturer representative regarding a patient who was receiving lioresal 1250 mcg/ml at 898. 5 mcg/day and dormicum 1875 mcg/ml at 137. 8 mcg/day via an implantable pump for an unknown indication for use. It was reported that when the refill is done at the due date there is always a discrepancy in the volume the n'vision states and the actual volume left in the pump. It was reported that contrast studies were done twice at different occasions with no catheter issues visible. The specific dates of the contrast studies was not known at the moment. It was reported that the actions taken were to book the refill prior to the actual refill dates were moved forward to prevent the pump being empty to avoid and prevent possible withdrawals. It was reported that the pump was removed 5 months prior to end of service (eos) and dr. (b)(6) asked to assess the pump as nothing is wrong with the catheter according to the physician and the contrast studies. It was reported that the physician and medtronic representative were not aware of any environmental/external/patient factors that may have led or contributed to the issue. It was reported that the pump was explanted and replaced on (b)(6) 2018 and that the patient was in good condition. It was reported that the issue was resolved at the time of this report. The patient status at the time of the report was alive-no injury. No further complications were reported and/or anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received. It was reported that the date of the event or the first noted volume discrepancy was not known as the doctor programs her patients herself. It was reported that the actual values of the discrepancies for each of the refills was usually between 6-9 ml. It was reported that the actual estimated volumes on the n'vision and the actual volumes aspirated from the pump were not known. The patient's weight at the time of the event was unknown. It was reported that there were no symptoms for the patient. It was reported that the implant date was approximately 7 years ago. No further complications were reported and/or anticipated.

Manufacturer Narrative

Additional information was received. It was reported that the correct dose of (b)(6) is 7. 9 mcg/day and the correct dose of (b)(6) is 11. 9 mcg/day. Analysis results were not available as of the date of this report. A follow-up report will be submitted when analysis is complete. 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.

Manufacturer Narrative

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

Manufacturer Narrative

The reported daily dose for lioresal was 898. 5 mcg/day and additional information received reported that the correct daily dose was 899. 5 mcg/day. The reported daily dose for dormicum was 137. 8 mcg/day and additional information received reported that the correct daily dose was 1,349. 3 mcg/day. Patient identifier (b)(6) no longer applies to this event. Analysis of the pump found overinfusion with an undetermined root cause. 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: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7601676
• MDR Text Key: 111068066
• Report Number: 3004209178-2018-13435
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Remedial Action: Recall
• 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: 06/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 03/28/2013
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2018
• 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?: Yes
• Date Device Manufactured: 10/04/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1570-2014

Patient Treatment Data

Date Received: 06/14/2018 Patient Sequence Number: 1