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

Model Number 97714

Device Problems Intermittent Continuity (1121); Energy Output To Patient Tissue Incorrect (1209); Overheating of Device (1437); Device Operates Differently Than Expected (2913)

Patient Problems Device Overstimulation of Tissue (1991); Therapeutic Effects, Unexpected (2099); Burning Sensation (2146); Complaint, Ill-Defined (2331)

Event Date 03/18/2018

Event Type  malfunction  

Manufacturer Narrative

Other applicable components are: product id: 39286-65, serial#: (b)(4), implanted: (b)(6) 2015, product type: lead.Other relevant device(s) are: product id: 39286-65, serial/lot #: (b)(4), ubd: 23-oct-2018, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer via manufacturer's representative regarding a patient who was implanted with a neurostimulator for spinal cord stimulation - complex reg pain syndrome type ii/spinal pain.It was reported that the patient was hit in the back with a car door.Patient now reported the lead felt like a hot poker in her back and it goes crazy on her, surging and coming on too strong, even with device off.Patient was told to turn all programs to zero and keep device off.Patient to be seen on (b)(6) by surgeon.Patient reported they were hit by car door while cleaning her car.Issue has not been resolved at this time.Patient is to be seen for x-rays (b)(6).Additional information was received from the patient via manufacturer's representative.It was reported that the patient's x-rays were completely normal as far as the stimulator was concerned.Patient stated she had a shoulder issue where her shoulder was rotating forward and pulling her back.The surgeon felt that was what caused the hot poker pain that she thought was the stimulator.Patient being referred to a shoulder specialist for evaluation and is planning to turn the stim back on and will let rep know if any further issues.

Manufacturer Narrative

Concomitant medical products: product id 39286-65, 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

Additional information was received from a manufacturer¿s representative (rep).The rep reported that x-rays are fine, leads are fine, problem was coming from shoulder rotating inward and pulling on spine at the lead site.The rep reported that the patient was being sent to a shoulder specialist.The rep reported that the patient had turned stimulation back on and understood that the sensations were not from the stimulator.No further complications were reported.

• 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: 7363590
• MDR Text Key: 103311070
• Report Number: 3004209178-2018-05587
• 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: 04/13/2018

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: 02/14/2016
• 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: 03/19/2018
• Initial Date FDA Received: 03/22/2018
• Supplement Dates Manufacturer Received: 03/22/2018
• Supplement Dates FDA Received: 04/13/2018
• Date Device Manufactured: 03/18/2015
• 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 Age: 71 YR