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 Intermittent Continuity (1121); Migration or Expulsion of Device (1395); Therapy Delivered to Incorrect Body Area (1508); Inappropriate/Inadequate Shock/Stimulation (1574); Malposition of Device (2616); Battery Problem (2885); Device Operates Differently Than Expected (2913)

Patient Problems Unspecified Infection (1930); Undesired Nerve Stimulation (1980); Pain (1994); Swelling (2091); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331); Malaise (2359); Sleep Dysfunction (2517); Electric Shock (2554)

Event Date 06/01/2013

Event Type  Injury  

Manufacturer Narrative

The main component of the system and other applicable components are: product id: 39565-65, serial# (b)(4), implanted: (b)(6) 2013, product type: lead.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for spinal pain.The patient reported that it worked wonderful for a couple months, but then issues began.The patient reported that the implanted device wouldn¿t hold a charge.The patient reported that she was told by her doctor at the time that it was her fault for not charging the ins but she had tried to charge it.The patient reported that the stimulation she received was in the wrong location and it was sporadic.The patient reported that the device shocked her and that the device still shocked her every now and then when she turned a certain way.The patient reported that there were no falls or traumas to contribute to this issue.The patient reported a loss of pain relief and return of target pain.The patient reported that the ins was implanted too close to the spine originally, so it was surgically revised further away.The patient reported that she had an infection related to the device that had made her sick, miserable, swollen, and in pain.The patient reported that she was swollen all the way down her leg.The patient reported that the incision sites were ¿caving in¿ and there was a ¿hole¿ where they moved the ins in her lower back.The patient reported that she was in extreme pain and was not currently able to work as a result.The patient reported that she couldn¿t sleep because the implant moved up into her robs and close to her hip bone.The patient reported that the place where the healthcare provider (hcp) attached the wires to her spine was sunken and getting deeper within the last 8 months.No further complications were reported.

• 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: 6753959
• MDR Text Key: 81400410
• Report Number: 3004209178-2017-15896
• 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
• Report Date: 07/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2014
• Device Model Number: 37714
• Device Catalogue Number: 37714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/27/2017
• Date Device Manufactured: 04/03/2013
• 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: 49 YR