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

Model Number 8637-20

Device Problems Incorrect, Inadequate or Imprecise Resultor Readings (1535); Volume Accuracy Problem (1675); Insufficient Flow or Under Infusion (2182); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); No Known Impact Or Consequence To Patient (2692)

Event Date 07/26/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Additional information was received from the manufacturer representative. It was reported that the patient's pump was refilled and the dose was cut by half, the patient was observed in hospital overnight, and was released the next morning. There were no further complications reported at this time.

Manufacturer Narrative

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

Event Description

Information was received from a healthcare professional (hcp) via a manufacturer representative regarding a patient who was receiving morphine [50 mg/ml] at a dose of 16 to 8 mg/day via an implantable pump for spinal pain. It was reported that the patient was at the clinic for a pump refill on (b)(6) 2018 and a reservoir volume discrepancy was observed where the expected residual volume (erv) was 3. 8 ml and the actual residual volume (arv) was 0 ml. It was noted that the doctor performing the refill was not the same hcp who did the previous pump refill so no historical data was available. It was also stated that the doctor was confident they were in the reservoir fill port during the refill on (b)(6) 2018. No complications were reported or anticipated.

Manufacturer Narrative

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

Manufacturer Narrative

(b)(4). 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: 7732827
• MDR Text Key: 115685552
• Report Number: 3004209178-2018-16972
• Device Sequence Number: 0
• Product Code: LKK
• 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
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 03/14/2018
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• 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 Answer Provided
• Date Device Manufactured: 09/15/2016
• 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: 07/30/2018 Patient Sequence Number: 1