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); Device Or Device Fragments Location Unknown (2590)

Patient Problems Scarring (2061); Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Event Description

It was reported that one anchor came apart and the inside titanium part was scarred in the generator pocket.The physician pulled the leads free from the pocket and the other part of that anchor and the other lead anchor were left inside the patient.The cause of the issue was not determined.The patient had stopped using the stimulation therapy since her rsd had gotten better and she no longer needed it.The patient was doing well.

Manufacturer Narrative

Concomitant medical products: product id neu_unknown, serial# unknown, product type: unknown; product id 3777-45, serial# (b)(4), implanted: (b)(6) 2009, product type: lead; product id 3777-45, serial# (b)(4), implanted: (b)(6) 2009, product type: lead; product id 3550-39, lot# n202076, implanted: (b)(6) 2009, explanted: (b)(6) 2015, product type: accessory; product id 37743, serial# (b)(4), product type: programmer, patient; product id 37752, serial# (b)(4), implanted: (b)(6) 2008, product type: recharger.(b)(4).Analysis results were not available at the time of this report.A follow-up will be sent when analysis is completed.

Manufacturer Narrative

Analysis of the lead (sn (b)(4)) found that the lead body conductor was broken at the anchor site, unknown.All wires were broken 19.5 centimeters from the distal end.Analysis of the lead (sn (b)(4)) found that the lead body conductor was broken at the anchor site, unknown.All wires were broken 19.4 centimeters from the distal end.Analysis of the anchor (sn (b)(4)) found that the anchor titan anchor separated.Analysis of the implantable neurostimulator (sn (b)(4)) found that the battery had reduced capacity due to overdischarge.The implantable neurostimulator (ins) was received with no telemetry.According to the trace report obtained from the ins after physician mode recharge (pmr) recovery, the total recharge count was 366.The last recorded recharge session performed while the device was implanted occurred on (b)(6) 2011.The device was recharged for 3hours 11minutes and the battery charged from 3.735volts to 4.020 volts.The battery discharged to the lock mode on (b)(6) 2012.The last patient usage was on (b)(6) 2012.A normal recharge was started manually after two physician mode recharges.Due to rapid discharge; three charge sessions occurred before obtaining the initial review and trace report.During the final charge the recharger had full coupling and the ins recharged for 22minutes from 3.505 volts to 3.790 volts.(b)(4).

Manufacturer Narrative

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

• 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: 4614204
• MDR Text Key: 16546733
• Report Number: 3004209178-2015-04986
• 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: Consumer,Company Representative,company representative
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/18/2015

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2008
• Device Model Number: 37712
• Device Catalogue Number: 37712
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/27/2015
• Initial Date FDA Received: 03/18/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; 04/27/2015
• Supplement Dates FDA Received: 04/28/2015; 05/15/2015; 09/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/13/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0500-2010
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention