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); Aspiration Issue (2883); Infusion or Flow Problem (2964)

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Additional information was received from the manufacturer¿s representative (rep) on 2018-jun-20. It was reported that it was unknown if further diagnostics/troubleshooting was performed, it was unknown what actions/interventions were taken to resolve the issues, it was unknown if the issue had been resolved, and the patient¿s weight was unknown. It was reported that serous fluid was not confirmed. The cause of the volume discrepancy and inability to aspirate was not determined. The current status of the device was ¿in use. ¿ the information was confirmed with the physician. There were no further complications reported/anticipated.

Manufacturer Narrative

Concomitant medical products: product id: 8709sc, serial# (b)(4), implanted: (b)(6) 2011, product type: catheter. Other relevant device(s) are: product id: 8709sc, serial/lot #: (b)(4), (b)(6), (b)(4). If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer via a company representative regarding a patient who was receiving hydromorphone with concentration 18 mg/ml at a dose rate of 10. 4 mg/day and bupivacaine with concentration 11 mg/ml at an unknown dose rate via an implantable pump for non-malignant pain and chronic low back pain. It was reported that at the last pump refill in (b)(6) 2018 (month and year specified only) a reservoir volume discrepancy occurred; 16 ml was the actual residual volume and the expected residual volume was 2 ml. There was no withdrawal symptom, but the patient experienced increased pain. The date of the increased pain was unknown. Regarding the reservoir volume discrepancy, it was indicated that the physician thought the practitioner maybe aspirated serous fluid instead of drug via the reservoir and that the patient would have had withdrawals without the intrathecal dose. The company representative did not think the patient had any other prescribed medications to take if they were not receiving the intrathecal medications. The company representative noted there was nothing reported for a possible pocket fill and no overdose symptom that the company representative was aware of. The company representative had utilized a clinician programmer on (b)(6) 2018. It was further reported that the healthcare provider (hcp) was unable to aspirate the catheter access port (cap), not measurable aspirate per the reporter, for a catheter dye study to confirm catheter patency. They tried utilizing 3 cc and 10 cc syringes and were still not successful with the aspiration, so a roller study was performed. The roller study was successful. No further patient complications have been reported as a result of this event.

Manufacturer Narrative

This field was corrected to include adverse event and product problem (previously product problem only. 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.

• 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: 7620968
• MDR Text Key: 112358207
• Report Number: 3004209178-2018-13899
• 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,consum

Reporter Occupation

• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/05/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 06/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 07/28/2019
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/08/2018
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 02/03/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial