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

Model Number 37714

Device Problems Energy Output Problem (1431); 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 05/30/2018

Event Type  malfunction  

Manufacturer Narrative

The main component of the system.Other relevant device(s) are: product id: 37761.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 degenerative disc disease/herniated disc pain and spinal pain.It was reported that the patient's desktop charger connector pin broke off on (b)(6) 2018, and on the same day the patient had a return of pain.A replacement desktop charger was sent to the patient, and on (b)(6) 2018 the patient called back to report they received the replacement.No out of box failure was reported and no further complications were reported or anticipated.

Manufacturer Narrative

Product id (b)(4) lot# serial# (b)(4) implanted: explanted: product type recharger h3: analysis of the desktop charger ((b)(4) ) found that the connector pins were broken: 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), fdm (b)(4), fdr (b)(4) and (b)(4) and fdc (b)(4) apply to the desktop charger.All patient codes, device code (b)(4) apply to the ins.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the patient reporting their return of pain was due to falling down twice this spring and more degenerative activity in their left hip.They noted that the replacement desktop charger did not completely resolve the return of pain, but it resolved some of it.Per the patient they really rely on it and if they did not have it they would not be able to get out of bed daily.No further complications were reported or anticipated.

Manufacturer Narrative

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 MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; 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: 7641422
• MDR Text Key: 112456876
• Report Number: 3004209178-2018-14432
• 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: 06/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2013
• 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: 09/17/2012
• 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: 57 YR
• Patient Weight: 95