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

Model Number 37711

Device Problems Migration or Expulsion of Device (1395); Unintended Collision (1429)

Patient Problems Bacterial Infection (1735); Purulent Discharge (1812); Pocket Erosion (2013); Injury (2348); Numbness (2415)

Event Date 04/03/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a patient with an implantable neurostimulator (ins) for the treatment of non-malignant pain and failed back syndrome ¿ other.It was reported that the patient collapsed on (b)(6) 2018.The patient had lot of wounds and had to see a wound doctor every week to remove bad tissue.The doctor was taking some tissue out of the wound where their ins was on (b)(6) 2018 when they saw a ¿pussball¿ and they drained it.It was confirmed that the pussball was not infected.The doctor was able to see through the wound and saw ¿a little piece of the stimulator.¿ it was reported that the patient¿s stimulator had ¿moved a little bit.¿ the patient also reported that their left foot has been completely numb since a week or two after the collapse and they may have a mri to determine the cause of the numbness.No further complications are anticipated.

Manufacturer Narrative

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

Event Description

Information was received from a patient with an implantable neurostimulator (ins) for the treatment of non-malignant pain and failed back syndrome ¿ other.It was reported that after the patient collapsed, they had to go to the hospital for several weeks.While they were in the hospital, they got "a severe strep infection in their bloodstream" and it settled in the back of the head and buttocks and the patient got wounds in those locations.No further complications are anticipated.

• Brand Name: RESTORE
• 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: 7580352
• MDR Text Key: 110870833
• Report Number: 3004209178-2018-12914
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2006
• Device Model Number: 37711
• Device Catalogue Number: 37711
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/05/2018
• Date Device Manufactured: 06/08/2005
• 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): Hospitalization; Other
• Patient Age: 44 YR