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

Model Number 97714

Device Problems Energy Output To Patient Tissue Incorrect (1209); Therapy Delivered to Incorrect Body Area (1508); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Undesired Nerve Stimulation (1980); Pain (1994); Electric Shock (2554)

Event Date 01/26/2018

Event Type  Injury  

Manufacturer Narrative

Other applicable components are: product id: 39565-65, serial# (b)(4), implanted: (b)(6) 2015, product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer via a manufacturer's representative (rep) regarding an implantable neurostimulator (ins) for the treatment of spinal pain.It was reported that the patient is feeling electrical shocks.The patient is also reporting that the stimulation has been off for four weeks, but they are feeling stimulation around their ribs.The patient was in the hospital the past week for chest pain and had diagnostics performed (monitoring, cath lab) and since then the ins has been turned off and the patient has been experiencing a band of tingling that wraps around the chest.The caller confirmed with the patient who indicated that they had been feeling this sensation about a week and a half prior to being in the hospital.The caller mentioned that the patient would normally feel residual stimulation when they turned the ins off.Prior to being in the hospital, the patient noticed that they turned the ins off the residual stimulation lingered for a few weeks, and they thought there might be an issue.The impedances are as follows: ref 0 - ranged from 1700-2400 ohms ref 4 - ranged from 1300-2000 ohms ref 10 - ranged from 1200-2000 ohms.The caller checked the adaptive stimulation diaries and the last entry was from (b)(6) 2018.The device appeared to have been off since then.The caller stated that they turned the ins on today and increased intensity, but this didn't change how the patient felt stimulation in the thoracic region or in the chest.The patient just felt stimulation more in their legs and knees.It was reviewed that the ins appears to be working appropriately and they could take x-rays just to ensure everything is in the correct place and no system damage is seen.The event started about two and a half weeks ago.No further complications were reported or anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received from the manufacturer representative.It was reported that the healthcare provider (hcp) decided to prescribe gabapentin on (b)(6) 2018 to relieve the feeling around the ribs that the patient was experiencing.The cause of the feeling around the ribs was not determined and it was not resolved at the time of the report.It was noted that this information had been confirmed with the hcp.No further complications were reported or anticipated.

• 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: 7302888
• MDR Text Key: 101163712
• Report Number: 3004209178-2018-04155
• 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,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/23/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2016
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/26/2018
• Initial Date FDA Received: 02/28/2018
• Supplement Dates Manufacturer Received: 02/28/2018
• Supplement Dates FDA Received: 03/23/2018
• Date Device Manufactured: 06/18/2015
• 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): Hospitalization
• Patient Age: 75 YR