MAUDE Adverse Event Report: MPRI EXTENSION; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number 3708140

Device Problems Component Missing (2306); Insufficient Information (3190)

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

Event Date 10/19/2018

Event Type  malfunction  

Manufacturer Narrative

Country: (b)(6).If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that ¿because the reported product was not attached with the screw, it could not be used.¿ it was further reported that the ¿setscrew was not missing¿ and that instead ¿it was not in the package from the beginning.¿ there were no external factors reported to have led or contributed to the event and there was no troubleshooting performed.It was noted the ¿issue did not occur when the new product was unpacked.¿ the extension issue remained unresolved at the time of report; the extension was replaced as a result of the issue.There were no complications reported or anticipated.

Manufacturer Narrative

Please note the extension serial number has been corrected from (b)(4) at this time.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Device evaluation: analysis of the extension found the setscrew was missing.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

• Brand Name: EXTENSION
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer (Section G): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 8070813
• MDR Text Key: 127259781
• Report Number: 2649622-2018-18679
• 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,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/05/2022
• Device Model Number: 3708140
• Device Catalogue Number: 3708140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2019
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/14/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/05/2018
• 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