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); No Device Output (1435); Improper or Incorrect Procedure or Method (2017); Low Battery (2584); Device Displays Incorrect Message (2591); Charging Problem (2892); Communication or Transmission Problem (2896)

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271)

Event Date 02/01/2017

Event Type  malfunction  

Manufacturer Narrative

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 with an implantable neurostimulator (ins) for the treatment of spinal pain.It was reported that the patient experienced a loss of therapy.The patient reported that they had been unable to recharge their ins for 1.5 months and the last successful recharge was 2 ¿ 3 months before the report.The patient also reported new pain at the ins site.No further complications are anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received reporting that the patient did not have any telemetry with recharging their device.It was reported that they had poor communication.They stated that they were trying to charge their implant last weekend and were not able to.Patient services had the patient reposition the antenna over their ins while on the call.They were asked to place the recharge antenna on the implant and then press the start charge button.The patient reported seeing the reposition antenna screen.It was attempted to be explained to the patient, the meaning of the screen, but they asked to speak with a spanish speaking agent.The patient was transferred to a spanish speaking agent.Additionally, it was reported that the patient could not connect with their external equipment and was seeing the reposition antenna screen.They stated that the last time they successfully charged the ins was maybe a month or 2 ago but they really couldn¿t remember.It was stated that the patient was in a lot of pain, because they could not turn their stimulation on as they couldn¿t charge it.They stated that they were taking medication for the pain.They reported that they use to have a phone number of a manufacturing representative, but they lost it.It was reviewed with the patient that their device was possibly overdischarged.The role of the rep was reviewed and the patient was redirected to follow-up with their healthcare provider to address the suspected overdischarge and discuss their symptoms.It was reported that the patient¿s pain, due to their stimulation being off began in (b)(6) 2017.The patient had poor communication with their external devices on (b)(6) 2017.No further complications were reported/anticipated.

Manufacturer Narrative

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

Event Description

Additional information received form the healthcare provider indicated that the patient was non-compliant with recharging their device.It was stated that the patient can communicate with their battery, but they just do not comply with or recharge the device.They noted that the patient was seen in the office on (b)(6 2017 by a manufacturing representative.No further complications were reported.

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 woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6418846
• MDR Text Key: 70423230
• Report Number: 3004209178-2017-05960
• 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: consumer,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2017
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/27/2017
• Date Device Manufactured: 03/10/2016
• 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 Age: 44 YR