MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SURESCAN; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number	97714
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Serious Injury
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¿s representative and a healthcare professional regarding a patient who was implanted with an implantable neurostimulator (ins).It was reported that there were high impedances on electrodes 8, 9, 10, 13, 14, and 15- they were greater than 20,000 ohms when they were checked at 1.5 volts.The patient reported no accidents or falls and don't know what could have caused the high impedances.The patient was reprogrammed using electrodes that were ok.The issue had not been resolved.Surgical intervention was not planned.No further complications reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information received from a manufacturer's representative.It was reported that the patient's ins was upgraded to a new system.The patient's new ins impedance values were within the normal limit.The representative noted that the ins would be returned for analysis.No further complications reported.
Additional Manufacturer Narrative
Analysis results were not available as of the date of this report.A follow-up will be submitted when analysis is complete.(b)(4).If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Analysis of the ins serial# (b)(4) found insignificant anomalies- the battery had reduced capacity due to an overdischarge.Conclusion code, method code, and result code no longer apply.Product analysis #(b)(4): analysis information -- 2019-03-04 12:32:10 cst pli# 10 product id# 97714 below is unedited, system generated text based on the analysis finding code(s).The returned device was subjected to a series of standard tests that include but is not limited to visual inspection, output and telemetry testing, and functional testing.Analysis identified that the implantable neurostimulator (ins) was functioning within specifications but has reduced capacity due to {x} overdischarge{s}.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: SURESCAN
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 7634258
• Report Number: 2649622-2018-10431
• Device Sequence Number: 14172889
• Product Code: LGW
• UDI-Device Identifier: 00643169464599
• UDI-Public: 00643169464599
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 09/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/28/2018
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2018
• Supplement Date Received by Manufacturer: 11/20/2018; 12/18/2018; 03/04/2019; 09/29/2020
• Initial Report FDA Received Date: 06/25/2018
• Supplement Report FDA Received Date: 12/04/2018; 12/18/2018; 03/07/2019; 09/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention