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

Model Number 8637-40

Device Problems No Audible Alarm (1019); Premature End-of-Life Indicator (1480); Premature Elective Replacement Indicator (1483)

Patient Problems Therapeutic Response, Decreased (2271); Distress (2329); Complaint, Ill-Defined (2331); No Known Impact Or Consequence To Patient (2692)

Event Date 08/25/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from the healthcare provider (hcp) regarding a patient receiving gablofen (200 mcg/ml at 1000 mcg/day) via an implantable infusion pump. The indication for use was intractable spasticity. It was reported that a refill was performed on (b)(6) 2019 and the elective replacement indicator (eri) was shown to be 33 months but on (b)(6) 2019 and the hcp used the tablet for the first time with the patient and in the logs it noted that eri had occurred on (b)(6) 2019. The caller stated the patient and their caregiver had not heard any alarms. No symptoms were reported. No further complications have been reported as a result of this event.

Manufacturer Narrative

Additional review of the provided information indicated that this section needed to be updated. 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.

Event Description

Additional information was received from a healthcare provider (hcp) via a company representative (rep) indicated the pump was replaced on (b)(6) 2019 and would be returned. The issue was resolved at the time of this report and the patient¿s status was ¿alive- no injury. ¿ the patient¿s weight and medical history were asked but unknown. It was also indicated the patient was receiving intrathecal lioresal (concentration and dose unknown). No further complications have been reported as a result of this event.

Manufacturer Narrative

Analysis of the pump found ¿pump - voltage related eri or eos - undetermined cause¿ and ¿pump ¿ low battery reset ¿ undetermined cause¿. 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: 9071371
• MDR Text Key: 162275074
• Report Number: 3004209178-2019-17717
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 10/28/2016
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2019
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/22/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/06/2015
• 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: 09/16/2019 Patient Sequence Number: 1