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

Model Number 8637-40

Device Problem Premature End-of-Life Indicator (1480)

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

Event Date 03/19/2019

Event Type  Injury  

Manufacturer Narrative

(b)(6).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a foreign healthcare professional (hcp) via a manufacturer representative regarding a patient receiving ropivacaine [8.0 mg/ml], sufenta [6 mcg/ml], prialt [4.5 mcg/ml], and catapressan [10 mcg/ml] via an implantable pump.The doses were not reported.The indication for use was not reported.It was reported the pump was refilled correctly on (b)(6) 2019.On that date, the pump was in elective replacement indicator (eri), and the replacement date was calculated as (b)(6) 2019.On (b)(6) 2019, the critical alarm went off, and the patient went to the hospital.After interrogating the pump, the nurse saw that the pump already reached end of service (eos).The programmer read ¿terminal event has occurred in the pump ¿ eos occurred ¿ eri occurred ¿ schedule to replace the pump by (b)(6) 2019.¿ early eos was suspected.The pump was implanted on (b)(6) 2016.Pump logs were not available.The patient did not experience any withdrawal symptoms.The pump was replaced and would be returned.No further complications were reported.

Manufacturer Narrative

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

Event Description

Additional information received reported that the programmed doses of ropivacaine [8.0 mg/ml], sufenta [6 mcg/ml], prialt [4.5 mcg/ml], and catapressan [10 mcg/ml] prior to eos occurring were 16 mg/24 hours, 12 mcg/24 hours, prialt 9 mcg/hours, and catapressan 20 mcg/hours respectively.It was also indicated that patient activated boluses were programmed as 1 mg of ropivacaine/0.75 mcg sufenta/0.56 mcg prialt/1.25 mcg catapressan [calculated from the other bolus doses] with a maximum of 24/day.(b)(4) was used to interrogate the pump.It was noted that the hcp did not have any additional information to share.

Manufacturer Narrative

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

Manufacturer Narrative

Analysis determined the pump reached end of service (eos) based on the number of motor revolutions.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Product id: 8870bbu01, serial# (b)(4), product type: software.Fdc updated for pump 8637-40, (b)(4).Fdm, fdr, and fdc apply for software card 8870, (b)(4).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: 8470004
• MDR Text Key: 140498916
• Report Number: 3004209178-2019-06394
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2017
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/19/2019
• Initial Date FDA Received: 04/01/2019
• Supplement Dates Manufacturer Received: 04/23/2019; 06/25/2019; 07/25/2019; 08/26/2019
• Supplement Dates FDA Received: 04/24/2019; 07/23/2019; 07/25/2019; 08/26/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2016
• 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