MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO PRIMEADVANCED; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number 37702

Device Problem Data Problem (3196)

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

Event Date 02/18/2020

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: neu_ptm_prog, serial#: unknown, product type: programmer, patient.Product id: a71100, serial#: unknown, product type: software.Other relevant device(s) are: product id: neu_ptm_prog, serial/lot #: unknown.Product id: a71100, serial/lot #: unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received by a manufacture representative (rep) regarding a patient with an implantable neurostimulator (ins).It was reported that the rep interrogated the patient¿s device with their tablet, then reprogrammed it and it was all good.However, they stated that when they then went to interrogate it again with the patient programmer, they got the ¿in the box¿ icon.The icon was reviewed and it was reviewed that the rep would need to interrogate the patient¿s device with the old physician programmer and then interrogate it with the tablet again to resolve the issue.The event occurred on (b)(6) 2020.No symptoms were reported.No further complications were reported/anticipated.

Manufacturer Narrative

Concomitant medical products: product id: neu_ptm_prog: product type: programmer, patient, product id: a71100: product type: software.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the rep.Rep stated the information for the programmer was not available.Rep provided the application version.The issue was resolved.Interrogating the battery with the 8840 and again with the clinician tablet cleared the "in the box" issue.Patient's weight was not available.The provided information was confirmed with the physician/account.

• Brand Name: PRIMEADVANCED
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; 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: 9782779
• MDR Text Key: 183797795
• Report Number: 3004209178-2020-04555
• Device Sequence Number: 1
• Product Code: LGW
• 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: 04/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2013
• Device Model Number: 37702
• Device Catalogue Number: 37702
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/17/2020
• Date Device Manufactured: 09/22/2011
• 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: 69 YR