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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS ILOW PROFILE EXTENSION

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MEDTRONIC PUERTO RICO OPERATIONS ILOW PROFILE EXTENSION Back to Search Results
Model Number 7482
Device Problems Device remains implanted; Wire(s), breakage of
Event Type  Malfunction  
Event Description

Patient reported to the mfr on (b)(6) 2006 they were diagnosed with open wire (extension), as shown by x-ray exam. The patient provided additional information to the mfr on (b)(4) 2007 regarding symptoms that included rigidity, difficulty walking, and tightness felt over the battery for the past two months. The patient also indicated they were scheduled for follow up with the hcp during (b)(6) 2007 for an internal system check because the physician is concerned that an open or short circuit is possible. The date x-ray films were obtained and prior date of consult with the physician was not reported. No report of device explantation has been received. The product was implanted in (b)(6) 2006. It is unknown if both extension products were affected. Additional information has been requested from the hcp. See mfr report number 2649622-2007-00177.

 
Manufacturer Narrative

(b)(4).

 
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Brand NameILOW PROFILE EXTENSION
Manufacturer (Section D)
MEDTRONIC PUERTO RICO OPERATIONS
rd. 149, km. 56.3
call box 6001
villalba PR 00766
Manufacturer (Section G)
MEDTRONIC PUERTO RICO OPERATIONS
rd. 149, km. 56.3
call box 6001
villalba PR 00766
Manufacturer Contact
lisa weik
710 medtronic pkwy
minneapolis , MN 55432-5604
7635051004
MDR Report Key2999653
Report Number2649622-2007-03568
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Consumer
Reporter Occupation
Type of Report Initial
Report Date 12/13/2006
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/12/2007
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date11/22/2009
Device MODEL Number7482
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received12/13/2006
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/23/2005
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 01/12/2007 Patient Sequence Number: 1
Treatment
IMPLANTED:
LOT #NFD103539H
EXPLANTED: UNK
EXPLANTED: UNK
EXPLANTED: UNK
LEAD: MODEL 3387, LOT #V005849
IMPLANTABLE NEURO STIMULATOR: MODEL 7428
LEAD: MODEL 3387, LOT #V005849
IMPLANTED:
IMPLANTED:
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