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

Model Number 8637-20

Device Problems Volume Accuracy Problem (1675); Insufficient Flow or Under Infusion (2182); Obstruction of Flow (2423); Material Integrity Problem (2978)

Patient Problems Therapeutic Response, Decreased (2271); Underdose (2542)

Event Date 05/02/2018

Event Type  Injury  

Manufacturer Narrative

Product id: 8781, serial# unknown, product type: catheter.Other relevant device(s) are: product id: 8781, serial/lot #: unknown.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 baclofen [1000 mcg/ml] at a dose of 466.8 mcg/day via an implantable pump for an unknown indication for use.It was reported on (b)(6) 2018 that the patient's therapy effect was unstable.The patient showed both underdose symptoms and good therapy effect.It was noted that the volume at the refill was more than the expected volume and that the hcp was planning a catheter revision.Logs were examined and attached with the report but did not show any significant events.No other diagnostics or troubleshooting was performed.There were no known environmental/external/patient factors that may have led or contributed to the issue.At the time of the report the issue was not resolved and the patient status was "alive - no injury" (note this is conflicting with the report of underdose symptoms.The patient's gender, age, weight, and medical history were asked but would not be made available.Other medications the patient was taking at the time of the event could not be obtained as they were not available to the manufacturer.No further complications were reported or anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received from a manufacturer representative on (b)(4) 2018.It was confirmed that both the unstable therapy effect/underdose and the volume discrepancy were both first observed on (b)(4) 2018.The serial/lot number of the catheter and the implant dates for the catheter and pump were not available.A dye study would be planned soon.Details related to the revision were unknown as the physician wanted to plan only the dye study at the time of the report.It was indicated that the provided information had been confirmed with the hcp.No further complications were reported or anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received from a manufacturer representative on 2018-jun-07.It was reported that the dye study was planned for the end of june.At the last refill the expected volume was 2.3 ml and the aspirated volume was 12 ml.No further complications were reported or anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received on 2018-jul-13.It was reported that the dye study was not yet performed and the revision was not yet planned.At the last refill the expected volume was 2.7 ml and the effective volume was 14 ml.

Manufacturer Narrative

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

Event Description

It was reported on (b)(6) 2018 that the dye study was still not planned but would probably be done in (b)(6).

Manufacturer Narrative

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

Event Description

Additional information reported that a dye study was not performed but a revision was performed on (b)(6) 2018.The physician noted a kinking and lesion on the pump segment near the pump connection; a photo of this was attached with the report.The physician replaced the pump segment and the patient was now receiving effective therapy and felt fine.

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.

Event Description

Additional information was received.It was reported the explanted portion of the catheter pump segment would not be returned for analysis because it was discarded.

• 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: 7483029
• MDR Text Key: 107221688
• Report Number: 3004209178-2018-09964
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2017
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/22/2018
• Date Device Manufactured: 08/25/2015
• 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