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

Model Number 97714

Device Problems Failure to Deliver Energy (1211); Failure to Interrogate (1332); Improper or Incorrect Procedure or Method (2017); Low Battery (2584); Communication or Transmission Problem (2896)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 09/30/2016

Event Type  Injury  

Manufacturer Narrative

Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.

Event Description

Information was received from a manufacturer's representative via a consumer regarding an implantable neurostimulator (ins) for the treatment of spinal pain.It was reported that the patient's device had entered over discharge.The patient reports that they charged the battery every other day and that the last time stimulation was felt was on wednesday (b)(6).The patient is unable to get signal with recharger or 8840.The patient had a physician mode recharge (pmr) in (b)(6).The representative initiated a pmr, and the patient refused to stay for the duration of the trickle charge.The patient was urged to continue the charge as another pmr would cause the need for a battery replacement.No further information at this time.The device was returned to the manufacturer on 2017-02-17.

Manufacturer Narrative

Analysis of the implantable neurostimulator (s/n (b)(4)) found no significant anomaly.The implant had reduced capacity due to overdischarge.The ins was received with no telemetry and no output from any electrode pair.Telemetry was restored after a full physician mode recharge.After telemetry was restored and a full normal recharge, the ins passed functional testing.According to the trace report taken from the ins, the last recharge while implanted took place on (b)(6) 2000 and the battery was charged to 3.080 volts.On (b)(6) 2016 the battery had depleted to the "lock" mode (<(><<)>(><(><<)><(><<)>)>3.575 volts).Subsequently, the battery depleted to an over discharged state prior to being received for analysis.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.

Manufacturer Narrative

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

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (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 clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6357208
• MDR Text Key: 68284690
• Report Number: 3004209178-2017-04559
• Device Sequence Number: 1
• Product Code: GZB
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2016
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/06/2015
• 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: 71 YR