MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION SYNCHROMED EL; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number 8627L18

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Headache (1880); Incontinence (1928); Unspecified Infection (1930); Urinary Tract Infection (2120); Discomfort (2330); Lethargy (2560); Weight Changes (2607); Partial Hearing Loss (4472); Insufficient Information (4580)

Event Date 01/01/2007

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a consumer regarding a patient who was receiving dilaudid and currently receiving saline via an implantable pump.The patient reported withdrawal back in 2007 when there was dilaudid in the pump.The patient stated that after the withdrawal their hair turned grey and they got arthritis.The patient further stated they were on antibiotics for a bladder infection and the physician told them it was incontinence.The patient stated then it was not urine because it was really thick liquid.Per the patient they think the infection was caused by the pump because over the years and last 6 months they have been having ear pressure and cannot hear right, gets lethargic, headaches and losing weight, now weighing (b)(6).The patient had a pelvic exam and there was a bad infection and was on antibiotics for 6 months and felt a lot better.But once they stopped the antibiotics the symptoms came back.The patient believed the pump was causing these issues.The patient was redirected to their healthcare provider.

• Brand Name: SYNCHROMED EL
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer Contact: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 11964325
• MDR Text Key: 255068143
• Report Number: 2182207-2021-00997
• 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: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2002
• Device Model Number: 8627L18
• Device Catalogue Number: 8627L18
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/17/2021
• Initial Date FDA Received: 06/09/2021
• 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 Weight: 40