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); Migration or Expulsion of Device (1395); Pocket Stimulation (1463); Charging Problem (2892); Device Contamination with Chemical or Other Material (2944); Appropriate Term/Code Not Available (3191)

Patient Problems Fall (1848); Undesired Nerve Stimulation (1980); Pain (1994); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271)

Event Date 08/17/2017

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 977a260, serial (b)(4), implanted: (b)(6) 2017, explanted: (b)(6) 2018, product type: lead.Product id: 977a260, serial (b)(4), implanted: (b)(6) 2017, explanted: (b)(6) 2018, product type: lead.The main component of the system.Other relevant device(s) are: product id: 977a260, serial/lot (b)(4), ubd: 22-jun-2021, (b)(4); product id: 977a260, serial/lot (b)(4), ubd: 22-jun-2021, (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a manufacturer representative (rep) regarding a patient with an implantable neurostimulator (ins) for spinal pain.It was reported that the ins was moved to a different location on (b)(6) 2018 due to the patient having trouble reaching the ins to recharge.The trouble recharging began in (b)(6) 2017.The rep met with the patient on (b)(6) 2018 to program.When stimulation was turned on, the patient felt ins site pain at 0.7 v and couldn¿t tolerate further programming.The patient doesn¿t feel pain at the pocket site with the ins off.The patient complained of stimulation in the battery pocket.Impedances were as follows: 1 - 765 ohms, 2 ¿ 917, 3 ¿ 972, 4 ¿ 959, 5 ¿ 995, 6 ¿ 1034, 7 ¿ 1014, 8 ¿ 845, 9 - >10k, 10 ¿ 867, 11 - >10k, 12 ¿ 787, 13 ¿ 702, 14 - >10k, 15 - >10k ohms.The patient was programmed on electrodes 4, 5, 6, 7.Therapy was fine prior to the revision.The rep said the cause of the pocket site pain was likely due to a fluid short.It was suggested the rep wait until the patient heals and hopefully the pocket would not be as sensitive to the stimulation, but a fluid short is not likely to go away.X-rays were performed, and it was determined that the leads were pulled into the battery pocket.The battery and leads were fully explanted.It was noted the patient falls every day.The issue was reported to be resolved.No further complications were reported.

Manufacturer Narrative

(b)(4).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.

• 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: 7705961
• MDR Text Key: 114555509
• Report Number: 3004209178-2018-16273
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2018
• 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: 08/08/2018
• Date Device Manufactured: 07/13/2017
• 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 Outcome(s): Required Intervention
• Patient Age: 49 YR