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 02/06/2020

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 37743, serial#: (b)(4), product type: programmer, patient, product id: 37092, serial#: unknown, product type: accessory, product id: a71100, serial#: unknown, product type: software.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a manufacturer representative regarding a patient with an implantable neurostimulator (ins) for rsd/ca usalgia-complex regional pain syndrome.It was reported that the caller saw the patient for a potential replacement and normal check-up as they believed the patient had not been seen since 2011.The patient went home and reported seeing an "in box" screen on the patient programmer.The caller didn't remember any error prompts when interrogating with the tablet and they clicked through all the prompts.The in box error was observed and this was a result of formatting and last being interrogated by an 8840 (clinician programmer) with an 8870 version aaq or older.The caller would use a clinician programmer and meet with the patient at a later date to interrogate and then use a tablet to confirm the issue was resolved.They reviewed that interrogating with an 8870 or later would resolve the issue.The call confirmed they could use an aau 8870 and it would.The caller also reported that the patient programmer was unable to communicate with or without that antenna attached.It had no telemetry.No symptoms were reported.No further complications were reported or anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received from a manufacturer representative (rep) reporting that the "in box" screen was resolved, and the patient's weight at the time of the screen was unknown.The physician was unable to confirm this information as they were unaware of the communication issue.No impact to the patient or their symptoms were reported.No further complications were reported or anticipated.

• 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: 9793180
• MDR Text Key: 182216898
• Report Number: 3004209178-2020-04700
• 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: 03/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2011
• Device Model Number: 37702
• Device Catalogue Number: 37702
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/05/2020
• Date Device Manufactured: 01/22/2010
• 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: 55 YR