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

Model Number 8637-40

Device Problems Application Program Problem (2880); Communication or Transmission Problem (2896); Adverse Event Without Identified Device or Use Problem (2993); Protective Measures Problem (3015)

Patient Problems Swelling (2091); Therapeutic Response, Decreased (2271); Anxiety (2328); Complaint, Ill-Defined (2331)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: a820, serial #: unknown, product type: software. If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received via manufacturer representative (rep) from a patient who was receiving morphine, unknown concentration at unknown dose via intrathecal drug delivery pump for non malignant pain. It was reported that following alert message occurred: no pump found. The patient attempted to give themselves a bolus this morning at 4:00 am, and the communicator read that the device could not be found. Patient confirmed that she was charging her communicator at 4:00 am and was on the call today to troubleshoot. She had an (b)(6) on her lap and moved away from the (b)(6) but still no pump was found. Where her pump was placed, it was hard for her to give herself a bolus. There was a "big swollen lump over her pump". The reported symptoms were panicking, nervous, anxious and possible withdrawal. No further complications were reported additional information was received from a healthcare professional (hcp) via manufacturer representative (rep). It was reported that pump pocket was swollen unable to interrogate. Patient was admitted and currently trying to find out the outcome of her in ot stay. Further follow up was in progress. No further complications were reported.

• 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: 8793653
• MDR Text Key: 151132408
• Report Number: 3004209178-2019-13589
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 11/14/2020
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/08/2019
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 05/24/2019
• 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: 07/16/2019 Patient Sequence Number: 1