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

Model Number 97712

Device Problems Disconnection (1171); Failure to Deliver Energy (1211); Entrapment of Device (1212); Migration or Expulsion of Device (1395); Energy Output Problem (1431); Device Operates Differently Than Expected (2913); Patient Device Interaction Problem (4001)

Patient Problems Unspecified Infection (1930); Scar Tissue (2060); Swelling (2091); Therapeutic Effects, Unexpected (2099); Foreign Body In Patient (2687)

Event Date 08/06/2016

Event Type  Injury  

Manufacturer Narrative

The main component of the system and other applicable components are: product id: 39286-65, serial# (b)(4), implanted: (b)(6) 2015, product type: lead.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

The consumer reported via the manufacturer representative that their system shut off when she was in certain positions.Reprogramming and troubleshooting was scheduled for (b)(6) 2016.The issue was not resolved at the time of the report.Further information received from the consumer reported that a wire was out of the unit so the left side did not work when she tried to change the program and it didn't do anything.The patient stated she had no therapy unless she was holding the battery.The patient was going to have surgery on (b)(6) 2016 to reseat the wire into the battery.The indication for use was non-malignant pain.

Event Description

Additional information was received from the patient via the manufacturer representative reporting that the patient had a swollen a rea on their neck near the lead incision site.This occurred on (b)(6) 2016.A ct scan was performed.Per the patient, the radiologist stated that the lead as "coiled around a muscle." the patient's medical history included complex regional pain syndrome (crps).

Manufacturer Narrative

Product event summary #evaluation determined that standard investigation is needed because it was reported that when the patient was in certain positions the system shut off, the left side did not work, they tried charging the program and it did not do anything, the wire was out of the unit, and a ct scan showed that the lead was coiled around a muscle.The reported information is an allegation that suggests a possible failure of a device, labeling, or packaging to meet specifications.An assessment of the source information indicates a potential relationship between the adverse event(s) reported and the alleged device failure.Assessment determined that there is not an existing formal investigation for the issue identified in this event.However, a new formal investigation is not possible, because there is inadequate information to initiate formal investigation activities; the root cause of the lead disconnection, migration around an organ, and programming/system issues remains undetermined.Follow-up was sent and a surgery was scheduled for (b)(6) 2016.Concomitant medical products: product id: 39286-65, serial# (b)(4), implanted: (b)(6) 2015, product type: lead.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

On 2016-08-21 (b)(6) (con,rep): *(information regarding the event related to the revision is omitted here, see pe (b)(4))* the consumer reported via the manufacturer representative that their system shut off when she was in certain positions.Reprogramming and troubleshooting was scheduled for 23-aug-2016.The issue was not resolved at the time of the report.Further information received from the consumer reported that a wire was out of the unit so the left side did not work when she tried to change the program and it didn't do anything.The patient stated she had no therapy unless she was holding the battery.The patient was going to have surgery on (b)(6) 2016 to reseat the wire into the battery.The indication for use was non-malignant pain.On 2016-08-11 (b)(6) (rep): additional information was received from the patient via the manufacturer representative reporting that the patient had a swollen area on their neck near the lead incision site.This occurred on (b)(6) 2016.A ct scan was performed.Per the patient, the radiologist stated that the lead as "coiled around a muscle." the patient's medical history included complex regional pain syndrome (crps).On 2016-10-05 (b)(6) (rep): additional information was received from a manufacturer representative regarding the patient.The patient had their entire system explanted by a healthcare professional.The patient will be treated with antibiotics and after six weeks of recovery, will have a system reimplanted.

Manufacturer Narrative

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

Manufacturer Narrative

Concomitant medical products: product id 39286-65, serial# (b)(4), implanted: (b)(6) 2015, product type lead; product id 39286-65, serial# (b)(4), implanted: (b)(6) 2015, product type lead.Due to imdrf harmonization, any previously submitted device, method, result, and conclusion codes no longer apply to this event.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from the consumer reported that she had an infection that was confirmed as a pseudomonas infection.The implant was removed and when they replaced it the new implant was on the left side because of all the scar tissue on the right side.

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (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: 5947141
• MDR Text Key: 54585673
• Report Number: 3004209178-2016-18813
• Device Sequence Number: 1
• Product Code: GZB
• 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,Followup,Followup,Followup
• Report Date: 01/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2015
• Device Model Number: 97712
• Device Catalogue Number: 97712
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/23/2019
• Date Device Manufactured: 01/17/2015
• 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): Required Intervention
• Patient Age: 50 YR