MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. RESTORE SENSOR; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number 37714

Device Problems Energy Output Problem (1431); Battery Problem (2885); Charging Problem (2892); Connection Problem (2900); Device Operates Differently Than Expected (2913); Material Integrity Problem (2978)

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271)

Event Date 01/01/2017

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 37791, serial# unknown, product type: recharger.Product id: 37761, serial# (b)(4), product type: recharger; product id: 37761, serial/lot #: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer regarding a patient implanted with a neurostimulator for the treatment of spinal pain.It was reported that the desktop charger connector pin was broken and the recharger screen was blank.It was also noted that the recharger antenna cord was frayed.The recharger would not charge the implant battery, so the battery went dead and the patient started having pain on (b)(6) 2018.No further complications were reported or anticipated.

Manufacturer Narrative

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

Manufacturer Narrative

Product id 37791 product type recharger product id 37761 serial#(b)(4) product type recharger analysis of the desktop charger ((b)(4)) found that the cable assembly had a frayed cord.Due to imdrf harmonization, some previously submitted device, method, result, and conclusion codes related to this event may have been updated.Device codes (b)(4) and (b)(4), device codes (b)(4), (b)(4), and (b)(4), apply to the desktop charger ((b)(4)).If information is provided in the future, a supplemental report will be issued.

• Brand Name: RESTORE SENSOR
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7659520
• MDR Text Key: 113392851
• Report Number: 3004209178-2018-14940
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00613994610430
• UDI-Public: 00613994610430
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2016
• Device Model Number: 37714
• Device Catalogue Number: 37714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2015
• 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: 47 YR