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

Model Number 97714

Device Problems Failure to Deliver Energy (1211); High impedance (1291)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Type  Injury  

Event Description

Additional information received reported a revision had not occurred or been scheduled.The patient was not receiving effective therapy at the time of this report.No outcome or interventions were reported regarding this event.Additional information could not be obtained at the time of the report.If additional follow-up is received, a follow-up report will be sent.

Event Description

It was reported that impedances were high, 0-7 8-15 were reported as greater than 10,000 ohms.Actions were not taken as a result of the event but there was a possible lead revision.The patient was going to discuss findings with the healthcare provider (hcp).Impedance testing was done.The patient was unable to feel stimulation with all three groups at 10.5 volts.The manufacturer representative met with the patient the day prior to the report and the impedance check showed all 16 contacts were out of range.The patient was getting less than 50% therapy relief at an unknown location.The patient status at the time of the report was alive, no injury.Information regarding if a revision was scheduled and patient outcome have been requested which was not reported regarding this event.If additional information is received, a follow-up report will be sent.

Manufacturer Narrative

Concomitant medical products: product id 977a260, serial# (b)(4), implanted: (b)(6) 2013, product type: lead; product id 977a260, serial# (b)(4), implanted: (b)(6) 2013, product type: lead; product id 97754, serial# (b)(4), product type: recharger; product id 97740, serial# (b)(4), product type: programmer, patient.(b)(4).

Manufacturer Narrative

Analysis of the lead(s/n (b)(4)) found all wires were broken at the distal end of the anchor 20.7 cm from the distal end of the lead.Analysis of the lead (s/n (b)(4)) found all wires broken 21.3 cm from the distal end of the lead.Analysis of the ins (s/n (b)(4)) found no significant anomalies.The ins was received with no telemetry.According to the trace report obtained from the ins after pmr recovery, the total recharge count was 36.The last recorded recharge session performed while the device was implanted occurred on 2014 (b)(6).The device was recharged for 2 hours 37 minutes and the battery charged from 3.675v to 4.000v.The battery discharged to the lock mode on 2015-oct-14.(b)(4).

Manufacturer Narrative

Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.

Event Description

Returned product- no new information.

Manufacturer Narrative

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

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; 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: 4184384
• MDR Text Key: 5014900
• Report Number: 3004209178-2014-19969
• 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,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2014
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/29/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/25/2013
• 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: 00034 YR