MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION; LEGGING, COMPRESSION, NON-INFLATABLE

Model Number NEU_UNKNOWN_PROG

Device Problem Human-Device Interface Problem (2949)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 8637-40, serial# (b)(4) implanted: (b)(6) 2013, product type: pump.(b)(4).

Event Description

Information received from a consumer patient with an implanted pump.Indication for use was noted as non-malignant pain and chronic low back pain.It was reported that the patient felt the manufacturer should make it easier for the physician to reach a representative when they "need to correct my pain pump when needed." the last time the physician was told he had to call back later.Event date, drug(s) in the pump, cause of event, circumstances that led to pump correction, symptoms, interventions, and outcome were not reported.Additional information has been requested, but was not available as of the date of this report.

• Type of Device: LEGGING, COMPRESSION, NON-INFLATABLE
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5460234
• MDR Text Key: 39208699
• Report Number: 3007566237-2016-01017
• Device Sequence Number: 1
• Product Code: LLK
• 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: Other
• Type of Report: Initial
• Report Date: 01/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NEU_UNKNOWN_PROG
• Device Catalogue Number: NEU_UNKNOWN_PROG
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/29/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1