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

Model Number 8637-20

Device Problems Obstruction of Flow (2423); Infusion or Flow Problem (2964)

Patient Problems Deposits (1809); Fall (1848); Loss of consciousness (2418); Sleep Dysfunction (2517)

Event Date 10/11/2021

Event Type  Injury  

Manufacturer Narrative

Concomitant products: product id: 8731sc, serial#: (b)(4), implanted: (b)(6)2010, product type: catheter. Other relevant device(s) are: product id: 8731sc, serial/lot #: (b)(4), ubd: 05-aug-2011, udi#: (b)(4). 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 bupivacaine (15 mg/ml) and dilaudid (30 mg/ml) via an implanted pump. The indication for pump use was non-malignant pain. The patient reported that last monday ((b)(6) 2021) he went for a catheter dye test and when the hcp (healthcare provider) went to pull on it ¿it was negative, he finally got a little bit then he tried again¿. Per the patient he went home after the procedure and was ¿very restless¿ and he ¿fell on the floor¿. At some point, he ¿completely passed out¿ and his neighbor found him on the floor and called 911. He stated that ¿they shot me with some narcan, and it helped¿. His physician told him that at the end of the catheter ¿it can grow crystals in that area¿ and ¿apparently when he did the dye study it blew all the crystals out and caused the overdose¿. On wednesday ((b)(6) 2021), the pump was turned down by 40% at the hospital. The patient mentioned that the pump was last increased 7 to 8 months ago. He stated that he was due to have his pump replaced in 4 or 5 months and was wondering if they should replace it now.

• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 12655948
• MDR Text Key: 277118693
• Report Number: 3004209178-2021-15528
• 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: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 12/14/2016
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 04/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/15/2015
• 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: 10/19/2021 Patient Sequence Number: 1