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

Model Number 97714

Device Problems Unintended Collision (1429); Inappropriate/Inadequate Shock/Stimulation (1574); Improper or Incorrect Procedure or Method (2017); Low Battery (2584); Device Or Device Fragments Location Unknown (2590); Battery Problem (2885); Device Operates Differently Than Expected (2913)

Patient Problems Device Overstimulation of Tissue (1991); Pain (1994); Complaint, Ill-Defined (2331); Loss of consciousness (2418); Electric Shock (2554)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a manufacturing representative (rep) and consumer regarding a patient who was implanted with a neurostimulator (ins) for non-malignant pain.Information was reported that the patient experienced over stimulation on her back in the er post fall and the device is in overdischarge.The impedance check showed they were within normal limits and there was no lead migration.The patient's ins was replaced due to overdischarge.The patient didn't charge her device and then the ins went into overdischarge.On (b)(4) 2018 the ins was replaced with a newer model.The doctor wanted to the battery analyzed due to the over stimulation she may have experienced in the er.No further complications were reported.No additional patient symptoms were reported.

Manufacturer Narrative

Analysis results were not available at the time of this report.A follow up report will be sent when analysis is compete.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the manufacturing representative (rep).It was unknown what caused the patient overstimul ation.No patient symptoms or complications were reported in this event.

Manufacturer Narrative

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

Manufacturer Narrative

The main component of the system and other applicable components are: product id 977a260, serial# (b)(4), product type: lead; product id 977a260, serial# (b)(4), product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from the consumer.It was reported that the patient fell about four years ago and kept getting shocked shortly after the fall.They went to the er because they would pass out from the pain.The patient spent six weeks in a nursing home unconscious because "they turned it on".The patient seemed to indicate that the unconsciousness was due to the stimulation being turned on.Their doctor removed and replaced their ins because their battery was "completely dead and no good".The patient reported that the stimulator was no good.Their hcp couldn't replace one of their leads because it was previously "super glued" to their spine.No further complications reported.

Manufacturer Narrative

Analysis determined that the implantable neurostimulator (ins) is functioning within specifications but has reduced capacity due to overdischarge.The ins had no telemetry and no output when it was received for analysis.A normal recharge started after (x) physician mode recharge{s} (pmrs).After recharging, there was good stable output from the ins and it passed the final functional test on the automated test console.The ins passed the final functional test on the automated test console.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SURESCAN
• 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: 7291933
• MDR Text Key: 100774153
• Report Number: 3004209178-2018-03830
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169109483
• UDI-Public: 00643169109483
• 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: company representative,consum
• Reporter Occupation: Patient
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2015
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2014
• 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