MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC X-STOP PEEK INTERSPINOUS SPACER; PROSTHESIS, SPINOUS PROCESS SPACER/PLATE

Catalog Number 1-3212

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

Patient Problems Pain (1994); Claudication (2550)

Event Date 07/31/2014

Event Type  Injury  

Event Description

It was reported that a patient underwent a surgery using an interspinous process system at l4/l5.The patient received unspecified oral medications for the treatment.The patient was discharged 16 days post-op.According ot the report, during follow-up at another hospital, pain recurred 16 months post-op.There was no fracture of the spinous process noted.The patient underwent additional surgery for removal of the interspinous spacer device with laminectomy because recurrence of intermittent claudication was also observed.The event outcome was reported to be unresolved after the revision since the intermittent claudication somewhat remained even after the surgery.The physician considered that the event of recurrence of pain was due to the patient-specific factor and was not causally related to medtronic products.The physician judged the interspinous process spacer as ineffective in this patient.

Manufacturer Narrative

(b)(4).Although it is unknown if any medtronic devices contributed to the reported event, we are filing this mdr for notification purposes.

• Brand Name: X-STOP PEEK INTERSPINOUS SPACER
• Type of Device: PROSTHESIS, SPINOUS PROCESS SPACER/PLATE
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinnea rd.; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: huzefa mamoola ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 4436320
• MDR Text Key: 21725314
• Report Number: 1030489-2015-00175
• Device Sequence Number: 1
• Product Code: NQO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P040001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/23/2014

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: 04/01/2013
• Device Catalogue Number: 1-3212
• Device Lot Number: 2261001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/23/2014
• Initial Date FDA Received: 01/21/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/29/2009
• 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: 00071 YR