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

Model Number 97714

Device Problems Failure to Deliver Energy (1211); Unintended Collision (1429)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Type  Injury  

Event Description

The patient has fallen three times since implant less than a month ago.The patient no longer felt stimulation that she used to.Additional information has been requested to find out more information regarding this even; if any intervention or troubleshooting was required and the outcome of the event.If additional information is received, a follow up will be sent.

Manufacturer Narrative

Product id 97740, serial# (b)(6); product type programmer, patient product id 977a260, serial# (b)(4), implanted: 2014 (b)(6); product type lead product id 977a260, serial# (b)(4), implanted: 2014 (b)(6); product type lead product id 97754, serial# (b)(4); product type recharger.(b)(4).

Manufacturer Narrative

Device analysis for ins (b)(4) revealed no significant anomaly.The ins battery was functionally okay.There were insignificant anomalies.Analysis for lead va0dpz9010 revealed no anomaly found.Analysis for lead va0lp3p027 revealed no anomaly found.Analysis for the bumpy anchor revealed no significant anomaly.The anchor was cut.Analysis for the bumpy anchor revealed no anomaly.

Manufacturer Narrative

(b)(4).

Event Description

Additional information received stated that after the patient had falls there was a sudden change in therapy.The patient was not getting therapeutic relief event after reprogramming, so the doctor chose to explant.The system was explanted on (b)(6) 2014.The system was not replaced with another manufacturer's product.There were no patient injuries reported.The patient recovered without sequela.

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 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: 4156661
• MDR Text Key: 4914171
• Report Number: 3004209178-2014-18615
• 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
• Remedial Action: Inspection
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/17/2014

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: 05/28/2015
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/12/2014
• Initial Date FDA Received: 10/09/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; 11/12/2014
• Supplement Dates FDA Received: 10/17/2014; 11/13/2014; 09/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2014
• 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: 00048 YR