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

Model Number 8637-20

Device Problems Vibration (1674); Environmental Compatibility Problem (2929); Unintended Electrical Shock (4018)

Patient Problems Cognitive Changes (2551); Electric Shock (2554)

Event Date 08/23/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a healthcare professional (hcp) and a consumer regarding a patient receiving bupivacaine (20 mg/ml at 6.087 mg/day) and dilaudid (25 mg/ml at 7.608 mg/day) via an implanted pump.The patient¿s medical history included stomach surgery in (b)(6) 2018 for gi (gastrointestinal) blockage that was unrelated her infusion system.The indication for pump use was non-malignant pain.On (b)(6) 2018 the hcp called with the patient on a speaker phone.Per the patient, the pump shocked her a week before she had an mri 3 weeks ago.During the mri, her pump was vibrating, and they had to stop during the mri because of her pump.She thought medication was released (a potential bolus) because she felt loopy/not normal.Then last week, she was shocked in her house when moving from room to room and she thought it was radiating from the pump location.At the time of the report, the patient was still experiencing the vibration sensation.No further complications have been reported as a result of this event.

• 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: 7897558
• MDR Text Key: 122177487
• Report Number: 3004209178-2018-21214
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100831
• UDI-Public: 00643169100831
• 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,health professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2016
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/20/2018
• Date Device Manufactured: 10/23/2014
• 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 Age: 55 YR