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

Model Number 97714

Device Problems Failure to Deliver Energy (1211); High impedance (1291)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 07/24/2017

Event Type  malfunction  

Manufacturer Narrative

Other applicable components are: product id: 977a260, serial# (b)(4), implanted: (b)(6) 2017, product type: lead.Product id: 977a260, serial# (b)(4), implanted: (b)(6) 2017, product type: lead.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a manufacturer¿s representative (rep) regarding a patient who was implanted with an implantable neurostimulator (ins) for spinal pain.The rep reported that the patient was just implanted and moved to the post-operative area and was feeling left sided stimulation.The rep reported that when impedances were ran, they ranged from 2,100-3,000 ohms with some values over 10,000 ohms when the top end of the lead was programmed.The rep reported that no intra-operative testing for coverage was done.The rep reported that antibiotic solution was used at the ins pocket and lead site and it was reviewed that this may cause a change with impedances.The rep reported that they would inform the healthcare provider (hcp) of current status with patient during post-operative visit.The rep reported that the patient wasn¿t feeling stimulation at top portion of both leads and when stimulation was felt, it was left sided.No further complications 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 it was decided to meet with the patient on (b)(6) 2017 to see if the issue had resolved itself.It was suggested that the use of antibiotic powder may have contributed to the lack of stimulation and the issue hadn't resolved 90 minutes post operation.

Manufacturer Narrative

Concomitant medical products: product id: 977a260, (b)(4), implanted: (b)(6) 2017, product type: lead, product id: 977a260, (b)(4), implanted: (b)(6) 2017, product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a manufacturer¿s representative (rep) on 2017-08-01.The rep reported that the patient got mostly left sided stimulation, but once the evolve settings were activated and he reported getting relief on (b)(6) 2017.The rep reported that the cause of the high impedances, patient not feeling stimulation and left sided stimulation had not been determined.The rep reported that the issue was resolved.No further complications were reported.

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (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: 6744044
• MDR Text Key: 81157401
• Report Number: 3004209178-2017-15587
• Device Sequence Number: 1
• Product Code: GZB
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2018
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/01/2017
• Date Device Manufactured: 07/03/2017
• 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: 60 YR