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

Model Number 97714

Device Problems Unintended Collision (1429); Device Displays Incorrect Message (2591); Battery Problem (2885); Charging Problem (2892); Communication or Transmission Problem (2896); Device Operates Differently Than Expected (2913)

Patient Problem Pain (1994)

Event Date 01/01/2017

Event Type  Injury  

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 who was implanted with an implantable neurostimulator (ins) for non-malignant pain.The patient reported that there was poor telemetry/communication or no telemetry with recharging.The patient reported that his ins was dead and it wouldn't charge.The patient reported that his ins had ¿been doing half charges¿ and it had not been charging all the way.The patient reported that 2 days prior to the report his ins completely died and a ¿bunch of pain started.¿ the patient reported seeing the reposition antenna screen but he had never seen that screen before when repositioning the antenna.The patient reported that the patient programmer (pp) said resync.The patient reported that he had only been able to do half charges for about a month now but the last time he recharged it he turned it down a bunch.The patient reported that he was waiting for a manufacturer¿s representative (rep) to call him back.The patient reported that he was supposed to get his ins ¿jump started¿ or get the battery replaced.The patient reported that he was in a lot of a pain and his back was throbbing and his legs were on fire.The patient reported that he went to the emergency room for the pain on the night prior to the report because it was so bad and got pain medication that didn't work.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 consumer through a manufacturer representative (rep) stating their ins would not communicate with the programmer and the recharger.Patient first noticed they couldn't charge the ins on (b)(6) and the last time they felt stimulation was on (b)(6).The patient was informed that the ins would not go in an overdischarged state that soon.The rep stated that the por message was the only thing that came up on the recharger after the ins was pulled out of overdischarge.The manufacturer representative will follow up with the patient on bypassing the por and charging the ins.The rep stated that the patient associates the issue to some degree with a fall they had on (b)(6) 2017 where the patient fell directly on the ins.Rep also mentioned that the patient fell off a ladder on to his back on (b)(6) 2017 but noted that there wasn't anything specifically related to that fall.After the fall on (b)(6), the patient noticed they couldn't charge the ins the next day, felt stim increased in intensity post-fall and then stopped feeling stim on (b)(6).No further patient complications have been reported as a result of this event.

Manufacturer Narrative

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.

Event Description

Additional information was received from a consumer.It was reported that the patient's ins died and had to be replaced.The patient stated that they had to wait 3 months to get the device replaced.The patient also stated that the battery had to be replaced as the battery would not charge.No further complications were reported or anticipated.

• 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: 6443039
• MDR Text Key: 71242789
• Report Number: 3004209178-2017-06594
• 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,Followup
• Report Date: 07/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2016
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/27/2017
• Initial Date FDA Received: 03/29/2017
• Supplement Dates Manufacturer Received: Not provided; 07/25/2017; 07/25/2017
• Supplement Dates FDA Received: 04/03/2017; 07/28/2017; 10/02/2017
• Date Device Manufactured: 02/12/2016
• 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 Outcome(s): Required Intervention
• Patient Age: 26 YR