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

Model Number 97714

Device Problems High impedance (1291); Unintended Collision (1429); Unable to Obtain Readings (1516)

Patient Problems Therapeutic Effects, Unexpected (2099); No Known Impact Or Consequence To Patient (2692)

Event Date 01/01/2016

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

Information was received from a consumer regarding an implantable neurostimulator (ins) for the treatment of non-malignant pain.It was reported that the patient had a fall in 2016 and gradually lost stimulation.The caller had a hip replacement due to the fall.The patient has high impedances as follows: at.7v lead 0-7 shows >10k, at 3v contact 1 and 3 show >40k and the rest showed xxx.The rep performed a short pmr and the impedances were retested.The xxx was gone but all showed > 40k.The caller dropped their reference and reference 1: only 0-7 shows >40k ohms, contact 2-6: ranging from 27k-36k ohms, 8-15: ranging 800-1400 ohms reference 2: contact 8-15 shows 23k-30k ohms.The caller was redirected to the healthcare provider (hcp) and an x-ray was suggested.No further complications were reported or anticipated.No symptoms were reported.

Manufacturer Narrative

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

Event Description

Additional information received from the manufacturer representative reported that they advised the patient to contact their surgeon¿s office to have an x-ray and discuss options.The cause of the high impedances was not determined and were not resolved.

Manufacturer Narrative

Should have been both adverse event and product problem.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SURESCAN
• Type of Device: 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
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; 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: 7485459
• MDR Text Key: 107470303
• Report Number: 3004209178-2018-10076
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169109483
• UDI-Public: 00643169109483
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2017
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/30/2018
• Date Device Manufactured: 07/26/2016
• 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: 84 YR