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

Model Number 8637-40

Device Problems Failure To Service (1563); Use of Device Problem (1670); Insufficient Flow or Under Infusion (2182); Device Displays Incorrect Message (2591)

Patient Problems Pain (1994); Loss of Range of Motion (2032)

Event Date 09/24/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a healthcare provider via a clinical study regarding a patient receiving dilaudid (250. 5 mcg/ml at 300. 18 mcg/day), bupivacaine (7. 3 mg/ml at 8. 7479 mcg/day), compounded baclofen, and clonidine via an implanted pump. The indication for use was spinal pain. It was reported the patient missed their pump refill appointment secondary to inpatient hospitalization. The patient presented for refill and interrogation revealed the low reservoir alarm occurred on (b)(6) 2017 at 07:16 and the empty pump reservoir occurred on (b)(6) 2017 at 23:27. The patient had worsening pain and decreased activity secondary to the worsening pain. It was indicated the event was related to the device or therapy and related to the drugs hydromorphone, clonidine, bupivacaine, and baclofen due to the low and empty pump reservoir alarms occurring. The pump was refilled on (b)(6) 2017 and the issue resolved without sequelae.

Manufacturer Narrative

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

Event Description

Additional information received from healthcare professional (hcp) via a clinical study indicated that the cause of the empty reservoir was due to the patient missing their refill appointment. The patient's baseline weight was (b)(6) pounds. No further complications were reported.

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: 7663733
• MDR Text Key: 113516100
• Report Number: 3004209178-2018-15030
• 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: health professional,study

Reporter Occupation

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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 01/14/2019
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• 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: 07/24/2017
• 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: 07/05/2018 Patient Sequence Number: 1