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

Model Number 8637-40

Device Problem Premature Elective Replacement Indicator (1483)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/10/2017

Event Type  Injury  

Event Description

Information was received from a healthcare professional via a manufacturer representative regarding a patient receiving gablofen (baclofen) 2000mcg/ml for a total dose of 799.1 mcg/day via an implantable pump for intractable spasticity.It was reported the manufacturer representative (rep) received communication from healthcare professional (hcp) today ((b)(6) 2017) regarding a premature elective replacement indicator (eri).3 months ago the eri was 51 months and today ((b)(6) 2017) when they interrogated the pump, eri had occurred with an end of service date of (b)(6) 2017 (per (b)(4)/print out).It was noted that no programming changes were done from 3 months ago to today ((b)(6) 2017).The rep inquired about design changes.It was noted that the rep with confer with the hcp and forward the event logs.No symptoms were reported.It was later reported the logs showed eri occurred on (b)(6) 2017 at 16:18 and schedule to replace pump by (b)(6) 2017 was displayed.It was also noted that the existing catheter was an 8709 with 26.5cm t rimmed.Refill interval was 95 days and low reservoir alarm was set for 2.0ml.No further complications were reported/anticipated.

Manufacturer Narrative

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

Event Description

Additional information received from manufacturer representative (rep) on (b)(6) 2017 reported the patient's pump was replaced today ((b)(6) 2017) and the hospital will be returning the pump for analysis.No further complications were reported/anticipated.

Manufacturer Narrative

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

Event Description

Additional information received from manufacturer representative (rep) on (b)(6) 2017 reported they attended pump replacement on (b)(6) 2017, and the pump will be returned for analysis.No further complications were reported/anticipated.

Manufacturer Narrative

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

Event Description

Additional information received from healthcare professional on 2017-sep-29 reported the patient's weight at time of event was (b)(6).No further complications were reported/anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received from the healthcare professional and the manufacturer representative.It was reported that the pump was disposed of at the explanting clinic.No further complications were reported/anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received from a consumer on 2017-nov-28; i t was reported that the pump failure for premature eri occurred in (b)(6) 2017 (note: this conflicts with the previous report and pump logs which indicated that eri occurred on (b)(6) 2017).

• 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: 6861893
• MDR Text Key: 86007990
• Report Number: 3004209178-2017-19251
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100824
• UDI-Public: 00643169100824
• 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: Nurse
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2016
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/28/2017
• Date Device Manufactured: 06/08/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 27 YR
• Patient Weight: 64