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

Model Number 97714

Device Problems Failure to Interrogate (1332); Improper or Incorrect Procedure or Method (2017); Low Battery (2584); Device Displays Incorrect Message (2591); Communication or Transmission Problem (2896)

Patient Problem Pain (1994)

Event Date 01/01/2015

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 consumer regarding a patient who was implanted with a neurostimulator (ins) for non-malignant pain and phantom limb syndrome.It was reported that there was poor communication on the patient programmer (pp) and no communication with the ins recharger (insr).The patient was instructed by his healthcare professional (hcp) on how to reboot it at home but it did not work.The patient reported that he had not charged his ins since before (b)(6) 2015 because he went to school and did not have the insr with him.The patient reported experiencing nerve pain across the shoulders.He was instructed to contact his healthcare professional to address the potential over-discharge.Additional information was received from a manufacturer¿s representative (rep) regarding a patient who was implanted with a neurostimulator (ins).The rep reported that there was an over-discharge.The rep reported that they did 2 physician recharge mode (prm), saw a power on reset (por) and the device was charging normally now.The rep reported that the patient was able to recharge up to 25%; however when they took a break to clear the por the clinician programmer was telling the rep that the battery was discharged.The rep reported that she thought this was the patients second over-discharge.No further complications anticipated.

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

Additional information was received from the manufacturer representative regarding the patient.It was reported that the power on reset (por) was cleared before the patient left the office.It was unknown what patient's weight was at the time of the event.No further complications were reported/anticipated.

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: 6417079
• MDR Text Key: 70423737
• Report Number: 3004209178-2017-05907
• 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: 03/24/2017

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: 01/28/2015
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/20/2017
• Date Device Manufactured: 03/12/2014
• 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 Age: 33 YR