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

Model Number 8637-20

Device Problems Pumping Stopped (1503); Insufficient Flow or Under Infusion (2182); Infusion or Flow Problem (2964); Protective Measures Problem (3015); Insufficient Information (3190)

Patient Problems Stroke/CVA (1770); High Blood Pressure/ Hypertension (1908); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331)

Event Date 06/01/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a consumer regarding a patient receiving dilaudid and clonidine via an implanted pump. The concentration and dose were unknown by the reporter but it had been the same for at least 6-10 months. On (b)(6) 2020 the patient¿s daughter reported that it was determined yesterday (b)(6) 2020 by the doctor that the patient¿s pump had stopped working in (b)(6) and now the hcp (healthcare professional) wanted to remove the pump due to this. The hcp also did a dye test yesterday and was unable to definitively locate the catheter. Per the reporter, the patient had been suffering horribly for the last 6 or 7 weeks and didn't know that it was due to the pump until the hcp informed her yesterday that the pump had stopped working. The patient¿s blood pressure was so high that she had a stroke. The reporter stated that if the pump stopped working and she was not getting the clonidine it would explain her blood pressure going up. She also stated that the patient had been having horrible symptoms and could have been going through withdrawal because the pump stopped working. No further complications have been reported as a result of this event.

• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 10431804
• MDR Text Key: 203715722
• Report Number: 3004209178-2020-14438
• 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
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date: 10/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 12/28/2017
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2020

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/27/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0497-2013

Patient Treatment Data

Date Received: 08/20/2020 Patient Sequence Number: 1