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

Model Number 97713

Device Problem Failure to Deliver Energy (1211)

Patient Problems Pain (1994); Vomiting (2144); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331)

Event Date 10/22/2020

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: neu_ptm_prog, serial#: unknown, product type programmer, patient.If information is provided in the future, a supplemental report will be issued.

Event Description

Patient (pt) reports last night something happened that never happened before because she was so much pain that she threw up because of the pain she was in and the pain made her feel like when she was bedridden.Patient states the pp was locked up / froze up and she could not get into the pp and the pp shows sn: (b)(4).Yesterday.Patient states she did troubleshooting with the patient programmer pp for one hour and replaced the pp batteries and she was able to use the pp to check implant and ins was off.Patient states she is concerned about her implant because she never turns ins off.Patient states she turned ins back on and the pain went away.Asked patient to sync with pp and pp shows therapy is on and setting.Caller was redirected to the healthcare provider (hcp) regarding her concerns.It was observed patient may be confused with information she saw on the pp screen last night.(b)(6) 2020 (b)(4), interface update detail (con): no new info.

• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 10804460
• MDR Text Key: 221281961
• Report Number: 3004209178-2020-19519
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169109490
• UDI-Public: 00643169109490
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2017
• Device Model Number: 97713
• Device Catalogue Number: 97713
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/23/2020
• Date Device Manufactured: 02/16/2016
• 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: 50 YR