MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO RESTORE ULTRA; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number 37712

Device Problems Break (1069); Material Separation (1562); Compatibility Problem (2960)

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

Event Type  malfunction  

Event Description

It was reported that the silicon sheathing pulled away from the metal portion of the anchor during removal of the titan anchor from the old lead.It was noted this had been a problem observed by the physician in the past.This reportedly did not cause any complications to the procedure.It was also noted that the physician mentioned that the lead regularly moved distally while applying the injex anchor.*of note: the above information was previously reported in mfr report # 3007566237-2014-01949.After further review, it was determined the events were related.Any additional information received will be reported in current mfr report #.Additional information received reported the patient¿s mri was not related to her stimulation system or therapy.The patient was reportedly having shoulder issues.Additional information received reported when the physician was replacing the system with a sure scan system, he noticed the silicon sheathing was pulled apart on the old system.The patient had no symptoms.No troubleshooting was done because the patient had no symptoms.

Event Description

It was reported that during removal of the titan anchor from the old lead, the silicon sheathing pulled away from the metal portion of the anchor.This did not cause any complications to the procedure.Additional information received reported the patient had the system removed and replaced because she needed to have multiple mris.It was noted the physician was removing the system with the titan anchor and replacing it with a surescan system.It was noted the patient¿s old system as working fine.

Manufacturer Narrative

Concomitant products: product id 97791, serial # unknown, product type accessory; product id 97792, serial # unknown, product type accessory; product id 3550-39, lot # n316694, explanted: (b)(6) 2014, product type accessory; product id 37744, serial # (b)(4), product type programmer, patient.(b)(4).

• Brand Name: RESTORE ULTRA
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• 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: 3927753
• MDR Text Key: 4556378
• Report Number: 3004209178-2014-12854
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2012
• Device Model Number: 37712
• Device Catalogue Number: 37712
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/07/2014
• Initial Date FDA Received: 07/10/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/29/2014
• Date Device Manufactured: 06/22/2011
• 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: 00065 YR