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 Migration or Expulsion of Device (1395); Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Staphylococcus Aureus (2058); Therapeutic Effects, Unexpected (2099); Meningitis (2389)

Event Date 03/20/2012

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 3777-60, serial#: (b)(4), product type: lead.Other relevant device(s) are: product id: 3777-60, serial/lot #: (b)(4), ubd: 03-feb-2015, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from the consumer regarding a patient who was implanted with a neurostimulator for spinal cord stimulation.It was reported that patient had a lot of problems with this ins.Patient noted that it was not hitting the target and was not going down for enough on her right leg.Patient added that there was always something with it.Patient stated their hcp started it wasn't really the unit itself but the leads, noting that the leads and anchors were replaced.Patient then stated that the leads moved after they were replaced and stated it was like 3 days after the leads and anchors were replaced that she got an infection; patient reported they had mrsa in their back and meningitis.Patient reported they think it was (b)(6) of 2014 that she got meningitis.Patient stated "this thing was fixed 9 times and on the 10th time" she got the infection.Patient then stated that the entire ins was removed and after waiting a period of time the new ins system was up in.No further complications were reported/anticipated.

Manufacturer Narrative

Product id: 3777-60, serial# (b)(4), product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the patient.The patient reported the lead went up and it was a device issue.The leads were replaced.Issue was resolved.

• 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: 9835872
• MDR Text Key: 183551262
• Report Number: 3004209178-2020-05453
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2013
• Device Model Number: 37714
• Device Catalogue Number: 37714
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/13/2020
• Date Device Manufactured: 02/23/2012
• 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 Outcome(s): Required Intervention
• Patient Age: 45 YR
• Patient Weight: 82