MAUDE Adverse Event Report: MPRI SPECIFY SURESCAN; STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)

Model Number 977C165

Device Problems High impedance (1291); Connection Problem (2900)

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

Event Date 10/03/2019

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 manufacturer representative regarding a patient who is implanted with a neurostimulator.It was reported that they did a new paddle lead implant on the day of the report and the check connectivity showed two contacts out (could not recall which two.) upon electrode impedance check, only contacts 6 and 7 showed greater than 40,000 ohms.The health care professional pulled out and repositioned the lead several times along with putting the lead into the 8-15 port of the implantable neurostimulator.When in the 8-15 port, 13 and 14 showed 40,000 ohms.It was confirmed that it was the same contacts as prior to swapping the ports.They ran impedances several times, and it was consistently the same contacts in either port that were over 40,000 ohms.The other contacts had normal, in range impedances.When the physician¿s assistant was inserting the lead into the header block, the lead bent slightly on the white marker band on the lead tail.They were not comfortable using the lead as most of the patient¿s pain is on the left side, so a new lead was used with no issues.There were no patient symptoms or complications reported.

Manufacturer Narrative

Analysis of the lead found no anomaly.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SPECIFY SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (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: 9162718
• MDR Text Key: 162138335
• Report Number: 2649622-2019-18191
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00643169464599
• UDI-Public: 00643169464599
• 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: 12/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/12/2023
• Device Model Number: 977C165
• Device Catalogue Number: 977C165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2019
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/27/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/12/2019
• 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: 42 YR