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

Model Number 97714

Device Problem Loss of Data (2903)

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

Event Date 01/06/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received by a manufacturing representative (rep) regarding a patient with an implantable neurostimulator (ins) for n on-malignant pain.Information was reported that the caller indicated that she was in a session with the ins and the tablet.The caller stated that the tablet automatically ended the session.When the caller tried to started a second session she got a message that if the user selected continue it would clear all of the data.The caller opted not to continue.The caller tried to reconnect again and got the same message about the ins information being cleared, so the caller did not complete the connection with the tablet.After the caller used an 8840 to interrogate the ins, the caller found that all of the therapy programming was cleared from the ins.The caller used the tablet report to get the same programming entered using the 8840.The caller did not have to re-orient the device.The caller stated that the report from the tablet session noted that the session was not ended properly.The app version being used was 1.0.4232 and the comm manager was 1.0.770.No further complications were reported.No patient symptoms were reported.

Manufacturer Narrative

Product id a71100, serial# unknown.Product type software if information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from the manufacturer representative reported that the cause was not determined and there were no logs available.

• 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: 9617351
• MDR Text Key: 175925823
• Report Number: 3004209178-2020-01579
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2017
• 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: 01/06/2020
• Initial Date FDA Received: 01/22/2020
• Supplement Dates Manufacturer Received: 01/22/2020
• Supplement Dates FDA Received: 02/13/2020
• Date Device Manufactured: 02/17/2016
• 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: 47 YR