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

Model Number 8637-40

Device Problems Battery Problem (2885); Infusion or Flow Problem (2964)

Patient Problems Diarrhea (1811); Muscle Weakness (1967); Pain (1994); Dizziness (2194); Discomfort (2330); Shaking/Tremors (2515)

Event Date 09/28/2021

Event Type  Injury  

Event Description

Information was received from a healthcare provider (hcp) via a company representative regarding a patient receiving dilaudid (5 mg/ml at 1. 3217 mg/day) via an implanted pump. The patient¿s medical history was noted to be chronic back pain, history of non-hodgkin¿s lymphoma, and status post covid. The patient¿s concomitant medication was noted to be hydrocodone (5/325 tid). The indication for pump use was non-malignant pain. It was reported that the patient¿s pump had been replaced in september due to approaching eri (elective replacement indicator). The medication from the old pump was transferred to the new pump and the patient was scheduled for a refill in october. Per the patient, since the replacement, she never felt she had good pain relief as she had in the past with the pump. After the refill on (b)(6) 2021, she was feeling more discomfort and had increased pain. She saw her hcp on (b)(6) 2021 for her post-op appointment and he recommended that she have a catheter dye study. A dye study was attempted on (b)(6) 2021 but the hcp was unable to aspirate the catheter. The roller study was normal. An mri was also done to rule out a granuloma. According to the patient¿s son, a couple of hours after the dye study, the patient developed withdrawal symptoms. She started feeling dizzy, had diarrhea, and was shaky and weak and this went on for 5 days until they were able to get a hold of the hcp¿s office. The patient was then prescribed hydrocodone for the withdrawal symptoms. On (b)(6) 2022 the patient was taken to surgery for a pump replacement and possible catheter replacement. At the time of the pump replacement, since the expected reservoir volume was 14. 7 ml and the amount withdrawn from the old pump reservoir was 15 ml, the hcp determined that the catheter was infusing so decided to do a back table prime of the new pump. The catheter was not checked, revised, or explanted during the procedure. It remained intact and in use in the patient. It was unknown if there were any environmental, external, or patient factors that may have led or contributed to the issue. The issue was noted to be resolved, and it was indicated that the hcp had no further information to provide regarding the event.

Manufacturer Narrative

Concomitant medical products: product id: 8709, serial#: (b)(4), implanted: (b)(6) 2002, product type: catheter. Other relevant device(s) are: product id: 8709, serial/lot #: (b)(4), ubd: 19-jun-2004, udi#: (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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 13470682
• MDR Text Key: 285154448
• Report Number: 3004209178-2022-01666
• 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,Company Representative

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 04/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2020
• 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: 02/07/2022 Patient Sequence Number: 1