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

Model Number 8637-20

Device Problem Material Integrity Problem (2978)

Patient Problems Dehydration (1807); High Blood Pressure/ Hypertension (1908); Vomiting (2144); Insufficient Information (4580)

Event Type  Injury  

Event Description

Information was received from a patient who was receiving dilaudid (unknown concentration or dose) via an implantable pump for unknown indications for use.It was reported that the patient's pain pump malfunctioned "about 2 months ago.I guess the catheter broke and having horrible withdrawals".The patient stated that they did a catheter dye study about 1 month ago and it was still not taken cared of.When asked dose and concentration of the dilaudid, the patient stated, "i think it was 0.2or at least it had a 2 in it".The patient stated, "i have missed 2 months of work" and noted that they just got out of intensive care the night before last ((b)(6) 2022) due to not getting medication. the patient noted that their physician did not give them anything to help with the withdrawals.The patient stated being severely dehydrated, vitamin deficiency, and extremely high blood pressure."i can barely keep anything down and the doctor doesn't seem to be in a hurry to help me".The patient was redirected to their healthcare provider to further address the issue.

Manufacturer Narrative

Concomitant medical products: product id: 8781, serial#: (b)(4), implanted: (b)(6) 2018, product type: catheter.Other relevant device(s) are: product id: 8781, serial/lot #: (b)(4), ubd: 26-sep-2019, 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: 14126404
• MDR Text Key: 290108717
• Report Number: 3004209178-2022-04828
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169530119
• UDI-Public: 00643169530119
• 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
• Report Date: 04/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2019
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/11/2022
• Date Device Manufactured: 10/17/2017
• 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): Hospitalization
• Patient Sex: Female