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

Model Number 8637-40

Device Problems Migration or Expulsion of Device (1395); Insufficient Flow or Under Infusion (2182); Obstruction of Flow (2423)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/09/2017

Event Type  malfunction  

Event Description

Information was received from a healthcare professional (hcp) via a clinical study regarding a patient receiving dilaudid (5 mg/ml at 1.5978 mg/day), bupivacaine (30 mg/ml at 9.587 mg/day), clonidine (400 mcg/ml at 127.82 mcg/day) and compounded baclofen (100 mcg at 31.96 mcg/day) via an implantable pump.It was reported that during a pump refill, on (b)(6) 2017, it was noted the pump had become inverted.The pump was manually repositioned to fill the pump.As a result of the pump inversion, the patient had difficulty activating their ptm and there was a reservoir volume discrepancy (irv: 15.9 ml, arv: 22 ml) from a probable catheter kink caused by the inversion.No action at this visit.Patient advised revision may be required, should the discrepancy continue.On (b)(6) 2017, the patient denied difficulty activating the ptm.The pump was refilled without note of inversion and the reservoir volume was minimal - irv: 20.7 ml and arv: 20 ml.It was indicated the event was related to the device or therapy.The issue resolved without sequelae on (b)(6) 2017.

Manufacturer Narrative

Concomitant medical products: product id: 8709, serial#: (b)(4).Product id: 8835, serial# (b)(4).Product id: 8709, serial/lot #: (b)(4), ubd: 11-feb-2012, 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: 14209498
• MDR Text Key: 290093688
• Report Number: 3004209178-2022-05248
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169508156
• UDI-Public: 00643169508156
• 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: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2017
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/25/2022
• Date Device Manufactured: 12/08/2015
• 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: 54 YR
• Patient Sex: Female
• Patient Weight: 87 KG