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 Problem (1431); Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099); Neck Pain (2433)

Event Date 07/24/2018

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: 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.Product id: 977a260, serial/lot #: (b)(4), ubd: 13-dec-2020, udi#: (b)(4); product id: 977a260, serial/lot #: (b)(4), ubd: 27-jul-2021, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient regarding their implantable neurostimulator (ins) for spinal pain.It was reported that on (b)(6) 2018, the patient woke up with pain in their neck area where the wires were implanted.It was reported the stimulation was painful and the patient was unable to turn the stimulation off.It was verified the stimulation was on so patient services assisted the caller with syncing to the ins and turning the stimulation off.It was confirmed it was turned off by checking that the lightning bolt was not present in the ins icon.After turning off the ins, the patient was still feeling the pain in their neck.They were redirected to their doctor to address the pain since it did not resolve.No further complications were reported or anticipated.

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.

Manufacturer Narrative

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

Event Description

Additional information was received from the patient.It was reported that the pain was an old pain for years.The cause of the neck pain was not determined.The patient tried programming, acupuncture, botox, inspected the stimulator, tens units, shots, and other methods to resolve the pain.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: 7723453
• MDR Text Key: 115691320
• Report Number: 3004209178-2018-16729
• 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: 12/12/2018

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: 06/14/2018
• 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: 07/24/2018
• Initial Date FDA Received: 07/26/2018
• Supplement Dates Manufacturer Received: 08/05/2018; 08/08/2018; 12/04/2018
• Supplement Dates FDA Received: 08/06/2018; 10/03/2018; 12/12/2018
• Date Device Manufactured: 07/24/2017
• 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: 83 YR
• Patient Weight: 70