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

Model Number	977C165
Medical Device Problem Codes	High impedance (1291); Connection Problem (2900)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem 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.
Additional 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
• Common Device Name: STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• MDR Report Key: 9162718
• Report Number: 2649622-2019-18191
• Device Sequence Number: 1189737
• Product Code: GZB
• UDI-Device Identifier: 00643169464599
• UDI-Public: 00643169464599
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2019

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2019
• Supplement Date Received by Manufacturer: 11/27/2019
• Initial Report FDA Received Date: 10/07/2019
• Supplement Report FDA Received Date: 12/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 42 YR