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

Model Number 97714

Device Problems No Device Output (1435); Charging Problem (2892); Device Operates Differently Than Expected (2913); Patient Device Interaction Problem (4001)

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

Event Date 06/06/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a consumer, via a manufacturer representative (rep), regarding a patient with an implantable neurostimulator (ins) for non-malignant pain.It was reported that the patient had an altercation with a police officer in which they were "tossed and turned like a ragdoll"; the police officer dropped their taser and the patient was tased in the toe.The patient said that since then they cannot charge the ins or turn on the therapy.The rep was able to interrogate the ins with no issues, there were no observations, impedances were 500-1000 ohms and the ins battery level was at 50%.The rep said they were trying to reprogram the patient and they were either unable to get coverage or when the rep did it was a painful stabbing feeling to the patient.The rep tried to adjust the pulse width down from 850 to 330 and that did not help.The healthcare professional ordered imaging.No further complications were reported.

Manufacturer Narrative

Due to imdrf harmonization, any previously submitted device, method, result, and conclusion codes no longer apply to this event.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a manufacturer's representative (rep).It was reported that cause was not determined.Rep stated they tried troubleshooting with patient services on the phone and were not able to find an issue with the leads or ipg.Rep reported they changed the pw to see if it would get a different response from the patient however, no success.It was reported that the patient commented that she had not been able to charge the device but at the time of visit the ipg was at 50%.The stabbing feeling the hcp ordered ct scan of the leads.It was reported the issues have not resolved and the patient left the office with the ipg in the off position due to the stabbing; still awaiting the follow up appointment.

Manufacturer Narrative

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: 7629507
• MDR Text Key: 112194364
• Report Number: 3004209178-2018-14104
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2016
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2018
• Date Device Manufactured: 11/15/2015
• 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 Age: 53 YR