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

Model Number 97714

Device Problems Charging Problem (2892); Device Operates Differently Than Expected (2913); Insufficient Information (3190)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/29/2018

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 patient who was implanted with an implantable neurostimulator (ins) for non-malignant pain.The patient reported that her device had not been working for a while.The patient reported that she had been trying since december last year, but she needed to get a new healthcare provider (hcp).The patient reported that the nurse at the new hcp office gave her a manufacturer¿s representative¿s (rep) phone number and told her to call the rep.The patient reported that she had been calling the rep and texting with her.The patient reported that the rep told her to hold the green and audio buttons until 60 minutes appears, until clock completes, if unable to resolve, repeat up to 4 times.The patient reported that she tried it friday and it didn¿t work, then she tried it again sunday and it didn¿t work.The patient reported that she told the rep this morning that it was still not charging and she sent the rep a picture of it via text message and the rep said to call the manufacturer for further troubleshooting.The patient reported that she was doing it for the third time during the call.No further complications were reported.

Manufacturer Narrative

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

Event Description

Additional information was received from the health care professional.Hcp provided further clarification on the device not working issue as patient did not use device or charge for several months.The cause was not determined and was provided as patient action.Actions/interventions taken to resolve the issue was attempted reprogramming.Issue was not resolved.Patient's weight at the time of event was (b)(6) pounds.No further complications were reported/anticipated.

• 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: 7664675
• MDR Text Key: 113397858
• Report Number: 3004209178-2018-15092
• 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: consumer,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2016
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/14/2018
• Date Device Manufactured: 06/14/2015
• 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: 47 YR
• Patient Weight: 96