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

Model Number 8637-20

Device Problems Migration or Expulsion of Device (1395); Obstruction of Flow (2423); Material Integrity Problem (2978)

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099); Burning Sensation (2146); Complaint, Ill-Defined (2331); Numbness (2415); Alteration In Body Temperature (2682)

Event Date 09/22/2017

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8780, lot/serial#: (b)(4), implanted: (b)(6) 2017, product type: catheter.Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 04-aug-2019, 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 morphine via an implanted pump.On (b)(6) 2020, the patient reported that she had back surgery in 1999 and then later received the pump.She was calling for mri compatibility guidelines.Per the patient, the pump never provided pain relief like the trial.She was now seeing a different doctor (not a pump doctor) who requested an mri to check her spine.She was having back pain.She stated the she also had a new pump doctor.Additional information was received on 24-sep-2020 from the patient who reported that she was not exactly sure of the cause for the pump not providing pain relief.She stated that she had been on morphine since she thought 2012.At implant, the ¿doctor left it sticking out of my stomach¿ and it would get caught on things and sometimes it burned behind it.They were getting ready to wean her off the morphine and remove the pump for good.The pain was in her butt cheeks, groin, and feet and she had started having shooting pains down the back of her legs.Her toes were numb but burned and felt like she was walking on glass and were very cold.The weaning process was starting on (b)(6).She had tried ¿medicines, different injections or different meds¿.She didn't know if it was helping her pain or not.She stated that she would find that out as she was being weaned off the morphine or how much it was helping.She stated that she never complained about the way the pump worked itself.It worked well until she fell from a ladder landing on her right heal which ¿knocked it out of place and cracked the tubing, clogged it¿.

• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 10598859
• MDR Text Key: 209134835
• Report Number: 3004209178-2020-16862
• 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: 09/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2019
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/24/2020
• Date Device Manufactured: 08/25/2017
• 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): Required Intervention
• Patient Age: 59 YR