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

Model Number 97702

Device Problems Low Battery (2584); Device Displays Incorrect Message (2591); Battery Problem (2885)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Concomitant products: product id 3550-29, lot # n536517, implanted: (b)(6) 2015, product type accessory; product id 97740, serial # (b)(4), product type programmer, patient; product id 977a260, serial # (b)(4), implanted: (b)(6) 2015, product type lead.(b)(4).

Event Description

The consumer reported that an elective replacement indicator (eri) was seen.It was first seen on (b)(6) 2015.There were no trauma or falls possibly related to the issue.There were no unrelated medical procedures.It was noted that the patient also had a device from a different manufacturer but it was more than 8 inches away and the patient wondered if this could have affected her implantable neurostimulator (ins).There was an allegation/dissatisfaction with ins longevity, as the patient was just implanted in (b)(6) 2015 and now she saw the eri.It was also noted that every morning the patient would turn stimulation off when she showered, because she had pain if she lifted her arm above her head to shower.It got worse if the stimulation was on, so she would turn stimulation off.This started before she got the ins, and it also did this with her other device.The pain started on (b)(6) 2012 when she got injured.It was noted that the patient had a history of non-malignant pain.Additional information was received from the patient saw their doctor on (b)(6) 2015 with a manufacturer representative (rep) and it was found that they had used 96% of the battery and it needed to be changed.The patient was having surgery on (b)(6) 2015 and the patient asked to replace the battery because it the patient felt that they thought that maybe something was wrong with this because since then it had gone dead.The patient was in extreme pain.It was noted that the device was put in on (b)(6) 2015 and for it to already fail was unacceptable.The patient indicating that on (b)(6) the ins was replaced on (b)(6) 2015 after lasting only 8 weeks with a nonrechargeable ins.The previous ins was being sent back to be analyzed.If additional information is received, the event will be updated.

Manufacturer Narrative

Additional review determined the following device code is also related to this event (b)(4).

Manufacturer Narrative

(b)(4).

Event Description

Additional information received from the patient reported that there was premature depletion.The patient had high settings and the device was supposed to last 18 months but only lasted 10 weeks.Stimulation was not as strong in (b)(6) 2015.They interrogated the implantable neurostimulator (ins) on (b)(6) 2015 and 96% of the battery was used.The device was going to be sent back for analysis.It was noted that the patient had a sore throat from intubation and was on crutches.

Event Description

Additional information was received from the patient reported that the implantable neurostimulator (ins) was replaced because it depleted 6 weeks post implant.The ins was sent in for analysis.The patient expected the ins to last 3-5 years.The revision had occurred and the patient recovered completely.No symptoms reported.

• 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 NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5056959
• MDR Text Key: 25031393
• Report Number: 3004209178-2015-17330
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 08/10/2015

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: 09/14/2016
• Device Model Number: 97702
• Device Catalogue Number: 97702
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/04/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/03/2016
• Date Device Manufactured: 03/23/2015
• 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: 00047 YR